Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,000 professionals servicing global clients. Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.

Your Work Matters.

At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company.  We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job 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/Skills

• 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

Education, Experience & Licensing Requirements

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

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 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.