Principal Quality Engineer - Marietta
1 month ago

Job summary
We are looking for a Principal Quality Engineer to support laboratory operations equipment validation and compliance in a GMP/GxP environment. This is a highly visible hands-on role for an experienced engineer who enjoys ownership accountability and technical depth.This role owns the full lifecycle of laboratory equipment including installation qualification requalification validation monitoring documentation and audit readiness. The Principal Quality Engineer acts as the technical and compliance subject matter expert for laboratory systems and equipment supporting cross-functional teams and mentoring junior engineers.
Key Responsibilities Own manage laboratory equipment lifecycle activities including installation qualification requalification validation retirement Design execute document equipment qualifications requalifications process validations in accordance with GMP regulatory standards Perform support temperature mapping continuous monitoring alarm investigations sterilizer autoclave qualifications Analyze raw data generate formal reports Support internal external audits ensure documentation accurate complete inspection-ready Author maintain quality protocols reports deviations CAPAs change controls risk assessments Collaborate IT CSV teams validate systems generating electronic data Part 11 compliance Serve technical point contact vendors service providers Train mentor junior engineers associates on use processes compliance Identify trends investigate failures drive proactive improvements performance compliance Participate site cross-functional process alignment efforts Requirements Bachelor's degree Engineering related scientific discipline Master's preferred Experience engineering validation within regulated environment Strong experience GMP/GxP industries pharmaceutical biotech medical device CRO Hands-on experience qualification validation requalification Supporting regulatory inspections audits Technical writing skills protocols reports deviations CAPAs Ability manage multiple priorities work independently mentor others Excellent attention detail organization documentation practices Work fully onsite Nice to Have Experience building automation continuous monitoring systems Familiarity CFR ISO standards Working Conditions Frequent standing walking hands-on work frequent lifting up to 50 lbs requires close attention active environments Important Note Must pass background drug screen Why Consider Role High ownership autonomy Opportunity act site-level subject matter expert Team culture integrity accountability collaboration Long-term stability regulated high-impact environment
Job description
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