Job Description
We are looking for a Compliance/Validation Engineer to join the Engineering Asset Management team and support execution of CQV (Commissioning, Qualification, Validation) and engineering compliance activities, in alignment with regulatory expectations and Good Manufacturing Practices.
How You Might Spend Your Days
- Authoring and reviewing CQV protocols, SOPs, and technical documentation, ensuring everything meets rigorous GMP standards and holds up under scrutiny.
- Leading investigations into deviations and non-conformances, driving CAPA implementation that gets to the root cause and keeps issues from coming back.
- Being a trusted voice for the engineering team during internal and external audits.
- Coordinating and executing engineering and quality change controls, keeping projects moving without compromising compliance.
- Drafting and executing CQV deliverables, from User Requirement Specifications to protocols, summary re...