Validation Engineer – Pharmaceutical & Medical Device (CQV, CSV, IQ/OQ/PQ)

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 equipmentExecute CSV activities for GxP computerized systems from URS through validation summary reportPrepare validation plans, risk assessments and requirements traceability matricesPerform field verification and system walkdowns, documenting and resolving discrepanciesInvestigate validation deviations and support root cause analysis and CAPA closureAssess change controls for validation impact and update affected documentationSupport audit and regulatory inspection readiness Qualifications Bachelor's degree in Engineering, Life Sciences or a related technical discipline3 5 years of validation experience in cGMP pharmaceutical, biotech or medical device manufacturingHands-on experience authoring and executing IQ/OQ/PQ protocolsWorking knowledge of 21 CFR Part 11 and/or 21 CFR Part 820Familiarity with GAMP 5 and risk-based validationExperience with deviations, change control and CAPAStrong technical writing and documentation skillsMust be legally authorized to work in the United StatesW2 employment only