Sr. Validation Engineer

Job Overview

As 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 will the ability to problem‑solve and prioritize activities to meet project deadlines.

• Develop IQ, OQ, PQ protocols using the company’s standardized validation system to ensure consistency.
• Continuously improve and update protocols to meet cGMP requirements.
• Coordinate equipment and facility qualification activities with Engineering, Maintenance, QA, Operations, construction firms, and validation contractors.
• Coordinate with Maintenance to repair system failures.
• Maintain validated systems as required by change control.
• Perform small validation studies.
• Drive re‑validation efforts to ensure systems continue to meet regulatory requirements.
• Perform or oversee execution of protocols, including gathering IQ documentation, resolving exceptional conditions, preparing final qualification reports, etc.
• Defend qualifications during FDA and customer audits.

• Knowledge of cGMP equipment and manufacturing operations.
• Demonstrated proficiency in Windows‑based environment including word processing, spreadsheets, and database programs.
• Desire to work with or knowledge of Distributive Control Systems.

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

Competitive benefits package that includes healthcare, life insurance, retirement planning, and more.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre‑employment screen. The screen may consist of 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.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.