Sr. Validation Engineer

Cambrex•Charles City, IA

6d•Onsite

About The Position

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.

Requirements

Knowledge of cGMP equipment and manufacturing operations
Demonstrated proficiency in windows based environment including word processing, spreadsheet, and data base programs
BS Chemical Engineering or other Engineering discipline preferred
2 or more years of experience in API manufacturing and/or pilot plant environment highly preferred
All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

Nice To Haves

Desire to work with or knowledge of Distributive Control Systems

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