Job Description:
Cambrex
Validation Engineer
US-IA-Charles City
Job ID: 2024-4048
Type: Regular Full-Time
# of Openings: 1
Category: Technical Service
Cambrex - Charles City
Overview
As a part of the Engineering Department, the Validation Engineer will assist with compliance of validation activities relating to facility and equipment qualifications throughout the plant. Interaction with all areas of the manufacturing plant site will be inherent to this position as well as the ability to problem solve and prioritize activities to meet project deadlines.
Responsibilities
- Developing IQ, OQ, PQ protocols by utilizing the Company’s standardized validation system to ensure consistency
- Working to continuously improve/update protocols to meet cGMP requirements
- Coordinating equipment and facility qualification activities between Engineering, Maintenance, QA, Operations, construction firms, and validation contractors
- Coordinating with Maintenance to repair system failures
- Maintaining validated systems as required by change control
- Performing small validation studies
- Driving revalidation efforts to ensure systems continue to meet regulatory requirements
- Performing or overseeing execution of protocols, including gathering IQ documentation, resolving exceptional conditions, preparing final qualification reports, etc.
- Defending qualifications during FDA and customer audits
Qualifications
- BS Chemical Engineering or other Engineering discipline preferred
- 2 or more years of experience in API manufacturing and/or pilot plant environment highly preferred
PI258912841
Salary:
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