Science,Science|Scientific Validator,Engineering Jobs

• We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
• Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Perform process revalidation activities and maintain validated manufacturing processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations, process improvements, and continuous improvement initiatives.

• Bachelor's degree in engineering, Life Sciences, or a related discipline.
• Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
• Experience supporting smoke studies and qualification activities.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

• We are seeking an experienced Process Validation Engineer to support new pharmaceutical manufacturing projects within a sterile GMP environment. This role will focus on process validation, technology transfer, and qualification activities for pre-filled syringe (PFS) manufacturing lines. The ideal candidate will have strong experience with aseptic processing, PPQ execution, and cross-functional collaboration to ensure successful project delivery and regulatory compliance.

• Develop and execute process validation strategies for new and existing sterile manufacturing processes.
• Lead Process Performance Qualification (PPQ) activities for pre-filled syringe (PFS) fill lines.
• Support technology transfer projects, ensuring seamless implementation of manufacturing processes across production lines.
• Coordinate and evaluate aseptic media fill studies to verify process performance and compliance.
• Perform process revalidation activities and maintain validated manufacturing processes.
• Support smoke studies and qualification activities for automated visual inspection systems.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and external partners throughout project execution.
• Prepare and review validation protocols, reports, risk assessments, and technical documentation.
• Ensure compliance with cGMP, FDA regulations, and industry best practices.
• Provide technical support for investigations, process improvements, and continuous improvement initiatives.

• Bachelor's degree in engineering, Life Sciences, or a related discipline.
• Experience in Process Validation within a pharmaceutical or sterile manufacturing environment.
• Hands-on experience with Technology Transfer and PPQ execution.
• Strong knowledge of aseptic manufacturing, media fills, and sterile processing.
• Experience supporting smoke studies and qualification activities.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Working knowledge of FDA regulations, cGMP, and validation lifecycle requirements.

Job Summary:

• You will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices.
• Focus will be assessing and testing the requirements of electromechanical medical devices at the system, sub-system, and part level; examples include ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and the accessories necessary for proper functionality of these types of devices.
• You will be a part of Our group works closely with the development team throughout the product development process.
• We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase.
• While having our own responsibilities within the group, we look to each other's strengths for support in doing our jobs.

Roles & Responsibilities:

• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Estimate resource needs for project support.
• Review requirements and scrutinize for testability.
• Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
• Assign project tasks and responsibilities to V&V team.
• Act as advisor to team to meet schedules and solve technical problems.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
• Execute test procedures both personally and using test technicians.
• Log defects and issues found during V&V activities and track to closure.
• Participate in defect review boards.
• Perform regression analysis and determine testing associated with design changes.
• Plan and facilitate V&V formal technical review and design review meetings.
• Provide weekly project status reports.
• Prioritize project tasks to complete on schedule while maintaining quality of work.
• Work in a team environment; peer review work.
• Work on multiple, concurrent projects.

Minimum Qualifications:

• Bachelor's Degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
• 5 years professional experience in the medical device industry.
• Working knowledge of global medical device regulations, requirements, and standards.

• Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
• Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
• Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
• Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
• Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
• Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
• Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
• Requirements:
• 5 to 10+ years in CSV/validation within regulated labs or life sciences.
• Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
• Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
• Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
• Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
• Excellent technical writing, organization, and cross- functional communication.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
• Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
• Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
• Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
• Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
• Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.

Key Competencies:

• Quality Validation & Compliance.
• CAPA Management.
• Regulatory Knowledge (FDA, GMP, GxP, QSR).
• Risk Assessment & Root Cause Analysis.
• Cross-Functional Collaboration.
• Project Management.
• Technical Documentation & Reporting.
• Continuous Improvement & Quality Excellence.

Skills need:

• 10+ years of experience in a Quality/Validation role.
• Strong background in quality validation, quality systems, and regulatory. compliance within the life sciences industry.
• Extensive CAPA experience.
• Extensive Quality Systems Experience.
• Extensive experience in high-speed aseptic filling operations and sterile manufacturing environments.

Job Summary:

• You will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices.
• Focus will be assessing and testing the requirements of electromechanical medical devices at the system, sub-system, and part level; examples include ventilators, sleep therapy devices, oxygen concentrators, personal wellness devices, and the accessories necessary for proper functionality of these types of devices.
• You will be a part of Our group works closely with the development team throughout the product development process.
• We play an active role early on in ensuring requirements are complete, unambiguous, and testable, collaborate to develop detailed test plans, and assist with development testing prior to the verification and validation phase.
• While having our own responsibilities within the group, we look to each other's strengths for support in doing our jobs.

Roles & Responsibilities:

• Learn from and adhere to internal quality manual (Quality System Procedures, Work Instructions, Forms).
• Interact with cross-functional project teams to provide inputs to project plans and schedules.
• Estimate resource needs for project support.
• Review requirements and scrutinize for testability.
• Develop V&V test plans, test procedures, requirements trace matrices, and test reports.
• Assign project tasks and responsibilities to V&V team.
• Act as advisor to team to meet schedules and solve technical problems.
• Quickly learn to use automated test tools and specialty test equipment; develop and validate Client test methods (TMV, DOE, Gage R&R studies).
• Execute test procedures both personally and using test technicians.
• Log defects and issues found during V&V activities and track to closure.
• Participate in defect review boards.
• Perform regression analysis and determine testing associated with design changes.
• Plan and facilitate V&V formal technical review and design review meetings.
• Provide weekly project status reports.
• Prioritize project tasks to complete on schedule while maintaining quality of work.
• Work in a team environment; peer review work.
• Work on multiple, concurrent projects.

Minimum Qualifications:

• Bachelor's Degree in an engineering discipline; electrical engineering or mechanical engineer background preferred.
• 5 years professional experience in the medical device industry.
• Working knowledge of global medical device regulations, requirements, and standards.

• Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5.
• Validate instrument software and lab systems; author URS, FRS, DS, test plans, IQ/OQ/PQ, traceability, and validation summary reports.
• Design and maintain infrastructure and data flow diagrams covering integrations, security, backup/restore, and audit trails.
• Capture business and technical requirements; maintain a bidirectional requirements traceability matrix.
• Execute test cycles, log defects, drive remediation, manage deviations/CAPA, and support inspections.
• Ensure change control, periodic review, training effectiveness, and release readiness for validated systems.
• Collaborate across QA/CSV, IT, and Lab teams; provide clear communication and stakeholder updates.
• Requirements:
• 5 to 10+ years in CSV/validation within regulated labs or life sciences.
• Strong knowledge of EMA Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and GAMP 5.
• Proven authorship of URS/FRS/DS, RTM, IQ/OQ/PQ, and validation summary reports.
• Experience with LIMS, ELN, CDS, or instrument control software; familiarity with instrument integrations and middleware.
• Proficiency with test and quality tools such as Client ALM/Jira/Xray, ValGenesis, Veeva, MasterControl, or TrackWise.
• Excellent technical writing, organization, and cross- functional communication.

• Support equipment qualification and GMP validation activities, including IQ, OQ, and PQ.
• Develop, execute, and review validation protocols, test scripts, and qualification documents.
• Prepare validation summary reports and maintain accurate documentation in accordance with cGMP requirements.
• Support validation deviation investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Ensure compliance with GAMP guidelines, 21 CFR Part 11, GDP, and data integrity standards.
• Review validation records for completeness, accuracy, traceability, and regulatory compliance.
• Collaborate with Quality Assurance, Engineering, Manufacturing, and other cross-functional teams.
• Support qualification of cell therapy manufacturing equipment, where applicable.
• Maintain validation documentation and ensure readiness for internal and external audits.

Education & Experience:

• Required: Bachelor's degree in engineering, Life Sciences, Biotechnology, Chemistry, or a related scientific discipline.
• Preferred: Relevant coursework or training in pharmaceutical validation, equipment qualification, GMP, or quality systems.
• Minimum of 5+ year of cGMP experience in the pharmaceutical, biotechnology, or life sciences industry.
• Hands-on experience supporting equipment qualification and validation activities, including IQ/OQ/PQ.
• Experience preparing, executing, and reviewing validation protocols and reports.
• Knowledge of cGMP, GAMP, 21 CFR Part 11, GDP, and data integrity principles.
• Experience supporting validation deviations and investigation documentation.
• Preferred: Cell therapy manufacturing equipment qualification experience.

Job Title: HiL Validation Engineer
Contract-Hire
Location: Lisle, IL
Onsite/ Remote: Day 1 Onsite at customer location

Description
Vector Tool Expertise: Utilize Vector tools such as CANoe, CANalyzer, VTestStudio & VT System for the validation of automotive electronic systems.
dSpace , ETAS LABCAR HiL & NI NATS HiL
Tool Expertise: Utilize dSpace tools such as Automation Desk, Control Desk, Motion Desk, Configuration Desk for the validation of automotive electronic systems.
Automation scripting: automation tools such as Python, EXAM, AutoDesk, ECUTest, VTestStudio, Robot framework or NI TestStand.
Deliverables: Verification and validation of features from domains like ADAS, Body and Powertrain. Automation and requirements for test tools (logging equipment, HIL benches, automation tools)
Test Plan Development: Create detailed test plans and strategies based on project requirements and specifications.
Test Execution: Perform various validation tests, including functional, performance, and integration testing, using Vector tools.
Automation Development: Develop and implement test automation scripts using Vector tools to streamline validation procedures or CAPL, Python scripting.

Required Expertise:
Minimum of 3+ years of professional engineering experience in electrical/electronics, hardware, software or controls as a LEAD
Strong Expertise in any one area - ADAS, Brakes, Active safety, Passive safety features, electric and Conventional ICE Engine features
Expertise in testing HiL systems experience (dSPACE, Vector, NI, ETAS)
Knowledge with model-based development tools such as MATLAB/SIMULINK
Experience of CAN stack, and Flash bootloader integration
Experience in diagnostic management: CANalyzer, CANoe
Familiarity using trace capture tools, data acquisition and analysis tools such as ETAS – INCA
Experience with HIL testing, vehicle integration and validation
Lead and Perform system level testing of any one - ADAS, Powertrain, Active/Passive safety, Brakes, Powertrain (ICE) in a HiL Testing environment
Leading the test team and participate in daily project specific sprint meeting
Preparing Test plans against system requirements, Scripting (Python, excel Macro) and test the scripts using HIL tools (dSpace Automation desk/Vector/ETAS/NI).
Good exposure to EXAM tool for test authoring.
Ensure requirement traceability- Feature spec to Test case and test results
Adherence to project specific metrics
Communicate across various stakeholders on the project and ensure adherence to project deliverables per planned timelines

Qualifications:
Bachelor's or Master's degree in Electrical Engineering, Computer Science.
Proven experience in automotive validation, with a focus on Vecto/dSpace tools and systems.
Strong knowledge of auto communication protocols (CAN, LIN, Ethernet, Flexray).
Extensive hands-on in feature enablement on HIL Test assets with test automation
Working knowledge in virtual simulation tools like CarMaker, ASM, etc.
Extensive Systems Engineering "V-Model" specifically requirements-based testing and design verification and validation.
Proficiency in scripting languages (e.g., Python, EXAM, CAPL) for test automation.
Excellent problem-solving and debugging skills.
Strong communication skills and the ability to work effectively in a team environment.

Preferred Qualifications:
Experience with automotive embedded systems and ECUs.
Familiarity with software development processes and tools.
Certification in relevant Vector tools OR ISTQB certified

• We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.
• The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with FDA, ISO 13485, and internal quality system requirements.
• Experience with infusion pump systems or similar electromechanical medical devices is preferred.

• Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
• Develop, review, and execute validation protocols, test plans, and test reports.
• Perform validation testing, document results, investigate failures, and support issue resolution.
• Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
• Support design verification, risk management, and product validation efforts.
• Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
• Participate in design reviews and provide technical input related to system validation.

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 10 years of Validation Engineering experience.
• Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
• Hands-on experience with System-Level Verification & Validation (V&V).
• Proven experience executing validation protocols, documenting results, and resolving validation issues.
• Strong understanding of design controls, validation processes, and quality systems.
• Excellent communication and documentation skills.
• Preferred: Experience working with FDA-regulated medical devices.
• Preferred: Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
• Preferred: Previous experience with client or other leading medical device manufacturers.