Sr. Validation Engineer in Charles City, Iowa at Cambrex

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.

• 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

• Knowledge of cGMP equipment and manufacturing operations
• Demonstrated proficiency in windows based environment including word processing, spreadsheet, and data base programs
• Desire to work with or knowledge of Distributive Control Systems

• BS Chemical Engineering or other Engineering discipline preferred
• 2 or more years of experience in API manufacturing and/or pilot plant environment highly preferred