Science,Science|Scientific Validator Jobs

Company Overview

Req ID: (phone number removed)

NTT DATA strives to hire exceptional, innovative, and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a candidate to join our team in Plano, Texas (US-TX), United States (US).

• GxP and Validation Strategy:
  • Develop and maintain the overall Computer System Validation / Computer Software Assurance strategy for the NetSuite implementation and associated applications.
  • Define the GxP impact, intended use, validation scope, system boundaries, criticality, and validation approach for each applicable computerized system.
  • Facilitate or lead Computer Software Risk Assessments (CSRA) and other system risk assessments.
  • Apply a documented, risk-based approach to determine the appropriate level of validation rigor and testing.
  • Establish clear validation boundaries between NetSuite, QCBD or other Quality Management Systems, integrations, interfaces, reports, workflows, and supporting applications.
  • Advise project leadership on validation-related go-live readiness and compliance dependencies.
• 21 CFR Part 11 and Regulatory Compliance:
  • Assess applicable system functionality against 21 CFR Part 11 requirements for electronic records and electronic signatures.
  • Evaluate controls including:
    • user access and security;
    • role-based authorization;
    • electronic signatures;
    • audit trails;
    • record retention;
    • data integrity;
    • system-generated records;
    • change control;
    • backup and recovery;
    • record availability and retrieval.
  • Ensure validation activities remain aligned with applicable predicate-rule requirements and company Quality Management System procedures.
  • Provide guidance on FDA expectations for computerized systems and risk-based Computer Software Assurance.
  • Support alignment with applicable medical-device Quality Management System Regulation (QMSR) requirements where relevant.
• Validation Planning and Documentation:
  • Develop or review the Computer System Validation Plan / Validation Strategy.
  • Define the required validation deliverables based on system risk and intended use.
  • Lead or provide oversight for preparation and approval of validation documentation, which may include:
    • GxP impact assessments;
    • CSRA / risk assessments;
    • validation plans;
    • user and functional requirements;
    • configuration specifications;
    • requirements traceability matrices;
    • test strategies;
    • IQ/OQ/PQ or equivalent risk-based verification protocols;
    • test scripts and test evidence;
    • deviation and defect assessments;
    • validation summary reports;
    • release and change-impact assessments.
  • Ensure validation documentation is clear, traceable, reviewable, and suitable for internal and external audit purposes.
  • Ensure critical requirements are traceable from intended use and risk through testing and final approval.
• NetSuite and SaaS Validation:
  • Define a practical validation approach for Oracle NetSuite as a cloud-based SaaS application.
  • Assess configured processes, workflows, roles, reports, integrations, scripts, custom fields, electronic approvals, and other GxP-relevant functionality.
  • Determine which NetSuite functionality is GxP critical and which functionality can be managed under standard business controls.
  • Establish an appropriate strategy for periodic NetSuite releases and application updates.
  • Review vendor release information and perform documented change-impact assessments.
  • Determine when regression testing or targeted revalidation is required following cloud releases or configuration changes.
  • Support validation of integrations between NetSuite and QMS, manufacturing, labeling, tax, banking, reporting, and other applications where those interfaces affect GxP records or processes.
• Data Integrity and Migration:
  • Assess data migration activities for GxP impact and validation requirements.
  • Define validation expectations for migration of regulated master data, historical records, transactional data, and reference data.
  • Ensure appropriate reconciliation, completeness checks, accuracy checks, and migration evidence are maintained.
  • Advise on data-retention and archival strategies for legacy GxP records that will not be migrated into NetSuite.
• Quality System Integration:
  • Work with Quality and business stakeholders to determine the appropriate system of record for regulated processes and records.
  • Ensure NetSuite and QMS responsibilities are clearly delineated.
  • Help determine which processes should remain within the existing QMS and which may appropriately be enabled in NetSuite.
  • Support development or revision of SOPs, work instructions, validation procedures, and system-governance processes.
  • Ensure validation deliverables are routed through the organization's approved document-control and Quality Management System processes.
• Testing and Execution Oversight:
  • Provide oversight and guidance to business SMEs executing validation protocols and user acceptance testing.
  • Ensure tests are risk-based and focused on critical business and compliance controls.
  • Review test evidence for completeness and adequacy.
  • Support investigation and disposition of validation deviations and defects.
  • Ensure unresolved issues are appropriately risk assessed before production release.
• Audit and Inspection Readiness:
  • Maintain validation documentation in an inspection-ready state.
  • Support internal Quality audits, customer audits, regulatory inspections, and third-party assessments.
  • Explain and defend the validation strategy, risk-based rationale, testing approach, and validation evidence when required.
  • Identify validation or compliance gaps and develop pragmatic remediation plans.
• Stakeholder Leadership:
  • Serve as the primary GxP / CSV advisor to project leadership.
  • Partner with Quality Assurance, Regulatory Affairs, IT, Finance, Supply Chain, Manufacturing, Engineering, and business process owners.
  • Translate regulatory requirements into practical system and process controls.
  • Facilitate workshops with business users to identify GxP critical processes, records, controls, and risks.
  • Provide training and coaching to project teams regarding CSV, Computer Software Assurance, Part 11, data integrity, and validation responsibilities.

Required Qualifications

• 8 years of relevant experience in GxP computerized system validation, Computer Software Assurance, quality systems, regulatory compliance, or regulated technology implementation.
• 8 years of demonstrated experience leading validation strategy for complex enterprise applications, ERP platforms, quality systems, manufacturing systems, or other GxP-relevant computerized systems.
• Strong practical knowledge of 21 CFR Part 11 and computerized-system validation principles.
• 8 years of experience developing and reviewing risk assessments, validation plans, requirements, traceability matrices, test protocols, validation evidence, deviations, and validation summary reports.
• 8 years of demonstrated experience applying risk-based validation principles rather than relying solely on prescriptive document-heavy validation approaches.
• 5 years of experience working within a regulated Quality Management System and controlled-document environment.
• 5 years of experience assessing electronic records, electronic signatures, audit trails, access controls, security roles, and data-integrity controls.
• 8 years of experience supporting system implementations, upgrades, releases, configuration changes, or SaaS/cloud applications.
• Ability to communicate complex regulatory and technical requirements clearly to both technical and non-technical stakeholders.
• Strong analytical, facilitation, documentation, and stakeholder-management skills.
• Bachelor's degree in life sciences, engineering, quality, information technology, computer science, or a related discipline, or an equivalent combination of education, training, and relevant professional experience.

Preferred Qualifications

• Experience validating Oracle NetSuite, Oracle Cloud, SAP, or a comparable enterprise ERP platform.
• Experience with regulated medical-device organizations.
• Knowledge of FDA Quality Management System Regulation (QMSR) and ISO 13485 principles.
• Familiarity with FDA Computer Software Assurance guidance.
• Knowledge of GAMP 5 and risk-based computerized-system lifecycle practices.
• Experience with Quality Management Systems such as QCBD or comparable electronic QMS platforms.
• Experience validating ERP integrations, master-data conversion, transactional-data migration, reporting, interfaces, and customizations.
• Experience supporting FDA inspections, notified-body audits, customer audits, or internal quality audits.
• Familiarity with manufacturing, supply chain, inventory, product traceability, lot/serial control, quality, and financial processes in a regulated environment.
• Relevant professional certifications in Quality, Regulatory Affairs, Validation, GxP, or Project Management are beneficial but not required.

Core Competencies

• GxP compliance and regulatory interpretation
• Computer System Validation / Computer Software Assurance
• 21 CFR Part 11
• Risk-based validation
• Data integrity
• Validation lifecycle governance
• SaaS and cloud-system validation
• Audit and inspection readiness
• ERP and QMS integration
• Requirements and traceability management
• Change control and release management
• Quality documentation
• Stakeholder facilitation
• Practical problem solving

Success Measures

The successful consultant will:

• Establish an approved and proportionate validation strategy before production deployment;
• Identify GxP-critical functionality and avoid unnecessary validation of non-critical functionality;
• Ensure critical system requirements and controls are traceable to objective validation evidence;
• Establish clear ownership between NetSuite, QMS, legacy systems, and interfaced applications;
• Enable completion of required validation deliverables before go-live;
• Establish a sustainable process for future NetSuite releases, changes, and revalidation; and
• Maintain documentation and system controls in an audit- and inspection-ready state.

About NTT DATA

NTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation, and management of applications, infrastructure, and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. Visit us at (url removed)

NTT DATA provides a reasonable range of compensation for U.S.-based positions. The starting pay range for this remote role is [$80.57 to $90.51]. This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on a number of factors, including the candidate’s actual work location, relevant experience, technical skills, and other qualifications. This position is eligible for company benefits including participation in medical, dental, and vision insurance, flexible spending or health savings account, and AD&D insurance, employee assistance, participation in a 401k program, and additional voluntary or legally-required benefits

NTT DATA endeavors to make (url removed) accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at (url removed). This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. For our EEO Policy Statement, please click here. If you’d like more information on your EEO rights under the law, please click here. For Pay Transparency information, please click here.

Full Time Contract

Title or Role: Senior Computer Systems Validation Associate
Compensation: Up to $60/hr., commensurate with experience
Location: Remote (Must be available to travel when validation protocol execution requires it)
Length of Contract: Up to 1 year

Position Description:
Our client is a growing pharmaceutical company who seeks a Senior Validation Associate with strong Computer System Validation (CSV) experience. As a Senior Associate, you will lead and be responsible for performing activities related to the Computer System Validation process for GAMP5 Category 3/4/5 GxP systems and qualification of GAMP5 Category 1 software tools. Working remotely, you will be involved in authoring and reviewing validation protocols, providing support for the change control process, reviewing vendor qualification documents, generating summary reports, performing periodic reviews, and supporting the CAPA process. During the execution process of protocols, you will be required on-site.

Responsibilities:

• Lead and manage computer system validation (CSV) projects, including scheduling vendor activities, authoring validation deliverables and protocols ensuring compliance with 21 CFR Part 11, Annex 11, GxP, and internal corporate policies.
• Authoring CSV deliverables such as Requirement Specifications, Risk Assessments, Traceability Matrix, Validation Plans, Validation Summary Reports, Installation Qualifications, System Acceptance Testing, and User Acceptance Testing, Periodic Reviews.
• Provide on-site support during the execution of validation protocols. Provide computer system validation training to other personnel, as applicable.
• Conduct Risk Assessments and participate in identifying the need for qualification and/or validation testing when implementing new software systems.
• Investigate and manage Deviations and CAPAs, and other quality system activities, including Periodic Reviews.
• Documenting activities following Good Documentation Practices (GDP), ensuring data integrity, system security, access control, and user safety are adequately addressed within validation documentation.

Qualifications:

• 10+ years of experience in FDA-regulated industries with strong knowledge of GMP, GAMP-5, 21 CFR Part 11, and Annex 11.
• 8+ years of experience in CSV document authoring, supporting SOP revisions, and protocol executions.
• Demonstrated ability to manage multiple concurrent validation or system implementation projects.
• Excellent written and verbal communication skills; strong collaborator with cross-functional teams.
• Self-motivated, adaptable, and customer-focused, with a proactive approach to leadership and problem-solving.
• Strong understanding of Good Documentation Practices and ALCOA+.

Education & Certifications:

• BS degree in science, engineering, computer science, or other science-related discipline.

Equal Opportunity Employer:
RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Pay Transparency:
RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices.

About RCM:
RCM is publicly traded on Nasdaq under the symbol RCMT.  RCM is a business and technology solutions provider with world-class talent in key market segments. We help design, build, and enable the Industries of Tomorrow, Today. Operating at the intersection of resources, critical infrastructure, and modernization of industries, RCM is a provider of services in Life Sciences, Data & Solutions (IT), Healthcare, Engineering, Aerospace & Defense, and Process & Industrial.

Disclaimer:
This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Title: Validation Specialist 2

Location: Fort Washington PA 19034

Duration: 11/09/2026 to 02/04/2028

Position Summary

The Specialist Technical Assurance provides testing, sampling, inspection, and technical support for the Quality Assurance department within the logistics area. The role serves as a Subject Matter Expert (SME) for sampling and inspection activities involving chemical components, bulk products, containers and closures, labeling, and packaging materials while ensuring compliance with GMP, safety, and quality requirements.

Key Responsibilities

• Perform sampling and inspection of:
• Chemical components
• Bulk products
• Containers and closures
• Labeling and packaging materials
• Support packaging material review and disposition activities.
• Prepare, label, and deliver samples to the laboratory for testing.
• Train and mentor sampling and inspection personnel.
• Support audits, regulatory inspections, and audit observation resolution.
• Assist with SOP revisions, process improvements, and continuous improvement initiatives.
• Track packaging component inspection and annual testing requirements.
• Maintain accurate GMP documentation and records.
• Participate in investigations and quality-related activities.
• Support safety, environmental, and compliance programs.

Required Qualifications

• High School Diploma or equivalent required.
• Minimum 4 years of experience in a pharmaceutical and/or OTC manufacturing environment.
• Warehousing and inventory control system experience required.
• Sampling and inspection experience in a pharmaceutical and/or OTC environment preferred.
• Strong GMP knowledge and compliance focus.
• Ability to work effectively with all levels of the organization.
• Strong interpersonal and teamwork skills.
• Basic computer proficiency.

Required Systems/Technical Skills

• SAP
• LIMS
• Microsoft Excel
• MS Office applications
• ERP systems
• Electronic batch records and automated quality systems experience preferred
• Preferred Experience
• Pharmaceutical/OTC sampling and inspection.
• Quality Assurance or Quality Control support.
• Packaging component inspection.
• Continuous improvement, Lean, and process excellence initiatives.

Job Description:
We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. The ideal candidate will be responsible for planning, executing, reviewing, and approving validation documentation for equipment, facilities, utilities, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.
Responsibilities:

• Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute equipment, process, cleaning, utility, facility, and computer system validation activities.
• Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation activities.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of:
  • IQ/OQ/PQ
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • Computer System Validation (CSV)
  • Risk Assessments
  • Change Control and CAPA
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Preferred Qualifications:

• Experience with MES, LIMS, SCADA, PLC, ERP, or other GMP computerized systems.
• Knowledge of Kneat, ValGenesis, TrackWise, MasterControl, or similar validation tools.
• Experience supporting audits and regulatory inspections.
• Validation certification or advanced degree preferred.

Job Description: We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. The ideal candidate will be responsible for planning, executing, reviewing, and approving validation documentation for equipment, facilities, utilities, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.
Responsibilities:

• Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute equipment, process, cleaning, utility, facility, and computer system validation activities.
• Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation activities.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of:
  • IQ/OQ/PQ
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • Computer System Validation (CSV)
  • Risk Assessments
  • Change Control and CAPA
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Preferred Qualifications:

• Experience with MES, LIMS, SCADA, PLC, ERP, or other GMP computerized systems.
• Knowledge of Kneat, ValGenesis, TrackWise, MasterControl, or similar validation tools.
• Experience supporting audits and regulatory inspections.
• Validation certification or advanced degree preferred.

Job Description: We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. The ideal candidate will be responsible for planning, executing, reviewing, and approving validation documentation for equipment, facilities, utilities, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.
Responsibilities:

• Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute equipment, process, cleaning, utility, facility, and computer system validation activities.
• Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation activities.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of:
  • IQ/OQ/PQ
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • Computer System Validation (CSV)
  • Risk Assessments
  • Change Control and CAPA
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Preferred Qualifications:

• Experience with MES, LIMS, SCADA, PLC, ERP, or other GMP computerized systems.
• Knowledge of Kneat, ValGenesis, TrackWise, MasterControl, or similar validation tools.
• Experience supporting audits and regulatory inspections.
• Validation certification or advanced degree preferred.

Job Description:
We are seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. The ideal candidate will be responsible for planning, executing, reviewing, and approving validation documentation for equipment, facilities, utilities, processes, and computerized systems while ensuring compliance with FDA, EMA, and cGMP regulations.
Responsibilities:

• Lead validation lifecycle activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Author, review, and approve validation protocols, reports, risk assessments, and validation plans.
• Execute equipment, process, cleaning, utility, facility, and computer system validation activities.
• Support commissioning and qualification (C&Q) activities for new equipment and manufacturing systems.
• Manage deviations, investigations, CAPAs, and change controls related to validation activities.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, GxP, FDA, EU GMP, and data integrity requirements.
• Support regulatory inspections and internal/external audits.
• Collaborate with Engineering, Quality Assurance, Manufacturing, Automation, and Regulatory teams.
• Mentor junior validation engineers and specialists.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmacy, Chemistry, or a related field.
• 5+ years of validation experience in a GMP-regulated environment.
• Strong knowledge of:
  • IQ/OQ/PQ
  • Process Validation
  • Equipment Qualification
  • Cleaning Validation
  • Computer System Validation (CSV)
  • Risk Assessments
  • Change Control and CAPA
• Experience with FDA, EMA, 21 CFR Part 11, and GAMP 5 guidelines.
• Excellent technical writing and documentation skills.

Preferred Qualifications:

• Experience with MES, LIMS, SCADA, PLC, ERP, or other GMP computerized systems.
• Knowledge of Kneat, ValGenesis, TrackWise, MasterControl, or similar validation tools.
• Experience supporting audits and regulatory inspections.
• Validation certification or advanced degree preferred.

Job Title - Validation Lead
Location - Raritan, NJ(Hybrid)
Buy Rate - $50/hr W2
Mandatory skills - Validation exp. Infrastructure and Tools – AWS/Azure etc.

Key Responsibilities:
• Candidates need to have hands-on experience in validating and implementing infrastructure systems and tools. e.g. AWS, Azure, JIRA, ServiceNow etc.
• Any recent experience with divestiture/separation in J&J a huge plus. e.g. Manufacturing site cutovers (infrastructure and applications),
• Ability to manage multiple dispositions for multiple J&J Managers with limited supervision.
• Must have proven track record of Large Acquisitions & Separations. Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
• Ability to manage end-end from Inventory, assessments, remediations to final dispositions; 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources. Specifically in the Pharmaceutical, biotechnology, or medical device industry.
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation; Define and implement Risk based validation activities.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports, SOPs/WIs). Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management

Position Summary:

• The Specialist 2, Validation / Technical Assurance provides critical testing, sampling, incoming material inspection, and technical support for the Quality Assurance department within the warehouse/logistics area. This individual serves as a Subject Matter Expert (SME) for sampling and inspection operations covering chemical components, raw materials, bulk products, containers/closures, labeling, and primary/secondary packaging materials, ensuring strict adherence to cGMP, FDA regulations, company SOPs, and safety standards.

Roles and Responsibilities:

• Incoming Sampling & Inspection: Perform compliant sampling, physical testing, and incoming inspection of raw chemical components, bulk drug products, container closures, labels, and packaging components.
• Packaging Disposition & Material Review: Support packaging material reviews, line clearance, component release, and disposition workflows within the warehouse and production areas.
• Laboratory Sample Coordination: Accurately prepare, label, package, document, and transfer samples to the Analytical/QC testing laboratories under strict chain-of-custody protocols.
• SOPs & Continuous Improvement: Draft, review, and update Standard Operating Procedures (SOPs); assist with process improvements, Lean manufacturing, and Operational Excellence (OpEx) projects.
• Audit & Inspection Readiness: Actively support internal quality audits and external regulatory inspections (e.g., FDA); assist in documenting, investigating, and resolving audit observations.
• Investigations & Deviations: Participate in quality investigations, non-conformances (Client), Out of Specification (OOS) findings, and root-cause analysis (RCA) within automated quality systems.
• Training & Mentorship: Serve as an SME to train, mentor, and qualify incoming sampling technicians and inspection personnel on cGMP techniques and sampling tools.
• Component Tracking & Metrics: Track annual testing cycles, re-inspection schedules, vendor qualification samples, and component shelf-life status in ERP/inventory systems.
• Compliance & Record Keeping: Maintain accurate, contemporaneous Good Documentation Practices (GDP) across Electronic Batch Records (eBR), LIMS, and SAP.

Qualifications & Experience:

• Education: High School Diploma or GED required (Associate or Bachelor's degree in Chemistry, Biology, Life Sciences, or related field is a plus).
• Experience: Minimum 4+ years of hands-on experience in a Pharmaceutical, Biopharmaceutical, or OTC manufacturing facility.
• Logistics & Warehousing Systems: Demonstrated experience with warehouse management systems (WMS), inventory control, and raw material intake workflows.
• Quality & cGMP Rigor: Strong knowledge of cGMP guidelines, 21 CFR Part 210/211, and Good Documentation Practices (GDP).
• Communication & Collaboration: Proven ability to communicate effectively across warehouse operators, quality control, lab analysts, and regulatory teams.
• Technical Systems & Tools
• ERP: SAP (WM/MM/QM modules preferred) or similar enterprise ERP.
• LIMS: Laboratory Information Management Systems (SampleManager, LabWare, etc.).
• Quality & Manufacturing Systems: Electronic Batch Records (eBR), TrackWise, Veeva Vault, or MasterControl.
• Office Applications: Microsoft Excel, Word, and Outlook.

Preferred Qualifications:

• Prior experience with AQL (Acceptable Quality Limit) sampling tables (e.g., ANSI/ASQ Z1.4).
• Background supporting Quality Control (QC), incoming inspection, or Quality Assurance (QA) release.
• Exposure to Lean, Six Sigma, 5S, or continuous improvement initiatives.

Job Title Validation Lead Job Location Raritan, NJ (Hybrid) Job Duration 6 month(s)+ (Contract)

• 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
• Experience in the Pharmaceutical, biotechnology, or medical device industry
• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
• Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
• Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
• Strong verbal and written communication skills.
• Ability to work as a team player, lead a team or accomplish tasks without supervision.
• Ability to work with remote teams and support several changes/projects simultaneously.
• Ability to provide Validation guidance, timely reviews, and escalations to TQ management

Role - Validation Lead
Location -Raritan, NJ(Hybrid)

Job Details:
5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.
Experience in the Pharmaceutical, biotechnology, or medical device industry
Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports
Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.
Strong verbal and written communication skills.
Ability to work as a team player, lead a team or accomplish tasks without supervision.
Ability to work with remote teams and support several changes/projects simultaneously.
Ability to provide Validation guidance, timely reviews, and escalations to TQ management