Sr. Validation Engineer
Northern, New Jersey
An industry leading pharma company is looking to a Sr. Validation Engineer to join their rapidly expanding team. This company has received tremendous recognition for its rich pipeline of drugs across a wide range of therapeutic areas. As a testament to this organizations continued growth this is a newly created role!
The Sr. Validation Engineer will have the following responsibilities:
- Support and assist in the creation of the qualification and validation programs
- Develop and execute on the qualification and validation programs
- Perform daily activities of the qualification, validation, and change management programs as required.
- Provide qualification, validation, and change management support and oversight for complex equipment or facilities projects.
- Evaluate, develop, and implement program improvements for the qualification, validation, change management, calibration, and maintenance programs for equipment, facilities, and laboratory instrumentation.
- Develop and review pre and post execution qualification and validation protocols (IQ, OQ, and PQ), calibration forms, and change management documents of equipment, facilities, and laboratory instrumentation.
- Audit equipment/facility files to ensure qualifications are complete and accurate, and subsequent changes have been properly documented. Perform remediation as required.
- Create or revise SOPs as needed.
- Track, trend, report on qualification, change management and calibration programs.
The ideal candidate will have the following skill set:
- Bachelor's degree.
- A minimum 2 years' experience in pharmaceutical validation
