Validation Engineer - Pharmaceutical & Medical Device (CQV, CSV, IQ/OQ/PQ)
Stark Pharma Solutions Inc
ABOUT COMPANY:
Stark Pharma Solutions Inc is a life sciences staffing and consulting firm supporting pharmaceutical, biotechnology and medical device organizations across the United States. We place quality, validation, manufacturing and regulatory professionals with companies building and scaling FDA-regulated operations. Our clients range from established manufacturers to early-stage sites standing up their first quality systems.
Validation Engineer Pharmaceutical & Medical Device (CQV, CSV, IQ/OQ/PQ)
JOB SUMMARY:
Our client, a life sciences manufacturer supporting both pharmaceutical and medical device product lines, is seeking a Validation Engineer to support commissioning, qualification and validation activities across manufacturing equipment, processes and computerized systems in a cGMP environment. This is a hands-on execution role working closely with Engineering, Manufacturing, Quality and Automation teams.
RESPONSIBILITIES:
- Author, review and execute IQ/OQ/PQ protocols for manufacturing, packaging and laboratory equipment
- Execute CSV activities for GxP computerized systems from URS through validation summary report
- Prepare validation plans, risk assessments and requirements traceability matrices
- Perform field verification and system walkdowns, documenting and resolving discrepancies
- Investigate validation deviations and support root cause analysis and CAPA closure
- Assess change controls for validation impact and update affected documentation
- Support audit and regulatory inspection readiness
QUALIFICATIONS:
- Bachelor's degree in Engineering, Life Sciences or a related technical discipline
- 3 5 years of validation experience in cGMP pharmaceutical, biotech or medical device manufacturing
- Hands-on experience authoring and executing IQ/OQ/PQ protocols
- Working knowledge of 21 CFR Part 11 and/or 21 CFR Part 820
- Familiarity with GAMP 5 and risk-based validation
- Experience with deviations, change control and CAPA
- Strong technical writing and documentation skills
- Must be legally authorized to work in the United States
- W2 employment only
Vacancy posted 3 days ago
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