What are the responsibilities and job description for the Process Validation Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Spearhead qualification protocols for next-generation manufacturing processes.
- Drive manufacturing investigations and implement innovative solutions.
- Design validation strategies for new product launches and technology transfers.
- Lead comprehensive IQ/OQ/PQ validation activities across multiple projects.
- Create robust standard operating procedures for manufacturing excellence.
- Ensure continuous process verification for robust manufacturing operations.
- Coordinate cross-functional initiatives for equipment and facility optimization.
- Champion continuous improvement through data-driven decision making.
- Working in a GMP-regulated environment.
- Supporting pharma or medical device manufacturing.
- Process validation documentation and execution.
- IQ/OQ/PQ processes and validation protocols.
- Regulatory & Production knowledge (Pharma/Med Device).
- 6 years of experience in a GMP-regulated environment required.
- Experience supporting manufacturing in the pharma or medical devices industry required.
- Experience with process validation documentation and execution required.
- Experience with IQ/OQ/PQ processes and validation protocols required.
- QMS experience required.
- Bachelor's degree required.
