SENIOR VALIDATION ENGINEER
Senior Validation Engineers are responsible for lifecycle document development, including validation master plans, IQ/OQ/PQ protocols, traceability matrix and FAT and SAT plans. They also will execute the protocols and plans as necessary. The Senior Validation Engineer will report in through the Operations group, working closely with engineering, project management and the client’s validation staff.
Senior Validation Engineers work as part of a larger project team, but also may work as seconded services, supplementing a client’s staff. They will review technical documentation, drawings and plant floor systems interfaces in order to develop test scripts and plans.
Key qualifications include:
- Ten or more years of validation experience in pharma, bio-tech or medical device industries
- A background in packaging equipment qualifications and computer system validation
- Experience in validating serialization solutions a plus
- Demonstrated ability to work independently
- Ability to travel domestically and internationally
- Engineering degree preferred