Overview
On Site
Full Time
Skills
Standard Operating Procedure
Manufacturing Operations
Optimization
Continuous Improvement
Decision-making
GMP
Manufacturing
Pharmaceutics
Medical Devices
Documentation
IQ
OQ
PQ
QMS
Job Details
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.
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