Senior Validation Engineer: Plant of the Future (Relocation)

NCBioImpact; Holly Springs (NC); Vor Ort; USD 95.000 - 176.000; Vollzeit

Benefits dieser Stelle

Relocation benefits

Zusammenfassung

Genentech in Holly Springs, NC seeks an accomplished Principal Validation Engineer to lead equipment qualification and process validation for a state-of-the-art drug product facility launching in 2028.

You will manage validation plans, execute CQ, PQ, RPQ/ CV/PV activities, collaborate across functions, mentor junior engineers, and drive a culture of operational excellence in a fast-paced, high-impact environment.

Qualifikationen

• Bachelor or higher in chemical/biochemical engineering or related field.
• 8+ years experience in drug product Process R&D, Engineering, Manufacturing, or Technical Services.
• Pharma/biotech industry experience required.
• Knowledge of cGMPs or equivalent regulations.

Aufgaben

• Develop and manage validation plans and timelines for qualification activities.
• Author, execute and summarize qualifications for sterilization, cleaning, filling and supporting equipment.
• Prepare change control documentation and reports for all activities.
• Support project manager to ensure timely implementation within budgets and forecasts.
• Lead risk management activities and participate in cross-functional teams.

Kenntnisse

Project management

Regulatory knowledge

Technical communication

Cross-functional collaboration

Problem-solving

Ausbildung

BS/MS in chemical/biochemical engineering

Jobbeschreibung

Genentech in Holly Springs, NC seeks an accomplished Principal Validation Engineer to lead equipment qualification and process validation for a state-of-the-art drug product facility launching in 2028.

You will manage validation plans, execute CQ, PQ, RPQ/ CV/PV activities, collaborate across functions, mentor junior engineers, and drive a culture of operational excellence in a fast-paced, high-impact environment.