Lab Validation Lead

Lab Validation Lead to support QC laboratory validation activities for a leading pharmaceutical and vaccine manufacturer located in Marietta, PA. The Lab Validation Lead will lead equipment qualification, analytical instrument validation, calibration programs, and computerized system validation efforts while partnering with quality, laboratory, engineering, IT, and global validation teams.

Responsibilities of the Lab Validation Lead:

• Lead validation lifecycle activities for QC laboratory equipment and systems.
• Author, execute, and review IQ/OQ/PQ protocols, reports, and validation documentation.
• Support qualification and lifecycle management of analytical instruments including HPLC, GC, balances, and environmental chambers.
• Manage calibration, maintenance, requalification, and vendor-supported services.
• Support computerized system validation, data integrity, access controls, and change management activities.
• Lead investigations, deviations, CAPAs, and audit readiness efforts.
• Partner with QC, Quality, Engineering, IT, and global validation teams to maintain compliance and operational excellence.
• Train personnel and provide technical leadership for validation activities.

Qualifications of the Lab Validation Lead:

• Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
• 5+ years of pharmaceutical, biotech, or vaccine industry experience.
• Experience supporting QC laboratory validation rather than manufacturing or production validation.
• Hands-on experience with analytical laboratory instruments such as HPLC, GC, and related systems.
• Strong experience writing and executing IQ/OQ/PQ protocols and validation documentation.
• Knowledge of cGMP, GxP, FDA regulations, computerized system validation, and data integrity requirements.
• Experience supporting audits, inspections, and vendor management activities.
• Strong communication skills with the ability to lead meetings and work across multiple stakeholder groups.
• Positive attitude, strong ownership mentality, and ability to work independently.