Validation Engineer
About The Position
The Validation Engineer is responsible for executing validation activities within a GMP manufacturing environment, including change control assessments and the review and approval of commissioning and validation documentation (protocols, reports, work orders, calibration, and preventive maintenance records). This role supports commissioning and qualification efforts across areas such as DQ, FAT, SAT, IQ, OQ, PQ, requalification, cleaning, sterilization/sanitization, computer systems, and process validation (PV). The position ensures all validation activities are scientifically sound, compliant, and aligned with regulatory requirements. Oversight (with limited supervision) of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of discrepancies Author, review, and approve validation and qualification documentation, including IQ, OQ, PQ, PPQ, validation plans, protocols, and summary reports in compliance with 21 CFR Part 210/211/11 and EU Annex 15 Author, Review and approve validation deliverables for projects of varying scale, including protocols, reports, and supporting documentation, and assess the validation impact of changes to systems and processes Generate, review, and support deviations, CAPAs, and root cause investigations, working closely with Quality Assurance to ensure timely and compliant resolution, including validation-related deviations; Develop, revise, review, and approve SOPs, validation procedures, and test strategies while supporting ongoing site data integrity initiatives Review and approve preventive maintenance and calibration plans, procedures, and associated documentation to ensure equipment remains in a validated state; Provide technical support to key site programs, including the cleaning program (cleaning validation, cleaning chemistry, and master plan) and Continued/Continuous Process Verification (CPV) Serve as a Subject Matter Expert (SME) during internal and external audits and regulatory inspections; Support vendor and service provider qualification activities, including participation in audits as required Other duties as assigned
Requirements
- Bachelor’s degree is required; Preferably in an Engineering discipline
- Minimum of 3 years of Manufacturing or Validation experience in a GMP manufacturing environment is required
- Strong understanding of FDA and EMA regulations and guidelines, including GAMP, ASTM E2500, ICH, USP, and 21 CFR Parts 210, 211, and 11 is required
- Experience reviewing commissioning, validation, and qualification documentation such as Validation Master Plans, FAT/SAT, traceability matrices, IQ/OQ/PQ, requirement specifications, and summary reports is required
Nice To Haves
- Experience with process validation and cleaning validation protocols is preferred
- Experience working with USP water systems, HVAC systems, and critical utilities (e.g., nitrogen, clean air), as well as equipment qualification is preferred
- Prior audit experience preferred
Responsibilities
- Execute validation activities within a GMP manufacturing environment.
- Perform change control assessments.
- Review and approve commissioning and validation documentation (protocols, reports, work orders, calibration, and preventive maintenance records).
- Support commissioning and qualification efforts across areas such as DQ, FAT, SAT, IQ, OQ, PQ, requalification, cleaning, sterilization/sanitization, computer systems, and process validation (PV).
- Ensure all validation activities are scientifically sound, compliant, and aligned with regulatory requirements.
- Oversight of production activities, including area clearance, issuance and review of batch records, and making decisions on initiation of discrepancies.
- Author, review, and approve validation and qualification documentation, including IQ, OQ, PQ, PPQ, validation plans, protocols, and summary reports in compliance with 21 CFR Part 210/211/11 and EU Annex 15.
- Author, Review and approve validation deliverables for projects of varying scale, including protocols, reports, and supporting documentation.
- Assess the validation impact of changes to systems and processes.
- Generate, review, and support deviations, CAPAs, and root cause investigations.
- Develop, revise, review, and approve SOPs, validation procedures, and test strategies.
- Support ongoing site data integrity initiatives.
- Review and approve preventive maintenance and calibration plans, procedures, and associated documentation.
- Provide technical support to key site programs, including the cleaning program and Continued/Continuous Process Verification (CPV).
- Serve as a Subject Matter Expert (SME) during internal and external audits and regulatory inspections.
- Support vendor and service provider qualification activities, including participation in audits as required.
Benefits
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 hours of PTO + 8 paid holidays
- Generous 401K match
- Medical, dental and vision benefits
- Tuition Reimbursement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
