Overview
On Site
Full Time
Skills
Regulatory Compliance
Asset Management
Management
Research and Development
GMP
Pharmaceutics
API
Manufacturing
IQ
OQ
PQ
Job Details
Responsibilities:
- Generate, execute, review, finalize, and approve validation/qualification protocols and reports.
- Manage and update project validation plans for specific projects.
- ssist and deliver amendments to the qualification(s) to ensure qualification compliance within agreed upon timelines.
- Utilize computerized asset management system for managing validation/qualification schedules.
- Generate operational and maintenance SOPs, FATs, URSs, FRSs, validation protocols and reports.
- Bachelor's degree required; B.S. in engineering preferred.
- Experience in an Engineering or a closely related role in a manufacturing or R&D environment.
- Experience in a GMP environment required. Experience in the pharmaceutical/API/chemical manufacturing industry preferred.
- Experience in a Validation Engineering role generating and executing.
- Commissioning, Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) protocols.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.