Validation Manager (Engineering)
a day ago
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OnsiteFull-timeMid
Summary
Penn Life Sciences is seeking a Validation Manager (Engineering) to join their team in Langhorne, PA. The role involves managing site commissioning and qualification, equipment qualification, and process and assay validation to ensure compliance with Quality System requirements.
About the Role
As a Validation Manager, you will be responsible for overseeing the validation staff, ensuring compliance with regulatory guidance, and maintaining the company's adherence to established Standard Operating Procedures and Current Good Manufacturing Practices. Your duties will include writing and executing validation protocols, compiling study data, troubleshooting atypical conditions, and providing scientific rationale for studies of new or modified GMP equipment and processes.
About You
Required:
- Bachelor's Degree preferred.
- 3-5 years of validation work experience in a GMP environment.
Preferred:
- Project management experience.
- Familiarity with Part 11 compliant electronic Quality Systems.
Penn Life Sciences
Penn Life Sciences is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. We take pride in our ability to advance medical care and offer low-cost alternatives in response to today’s healthcare challenges.
Langhorne, PA