Company Information
Take charge of your career and grow in new directions by exploring opportunities within a growing Life Sciences Company.
Cambrex Charles City, Inc. is a subsidiary of Cambrex Corporation (NYSE: CBM). Headquartered in East Rutherford, NJ. Cambrex Corporation provides products and services to accelerate the development and commercialization of branded and generic small molecule therapeutics. Cambrex supports its customers worldwide with R&D and cGMP manufacturing facilities in the US and Europe, maintains an excellent regulatory compliance record and provides strong expertise in various chemical technologies. Cambrex Charles City, Inc. develops and manufactures active pharmaceutical ingredients and pharmaceutical intermediates for a wide range of applications.
We are seeking a Validation Engineer to work in our Charles City, Iowa location who shares the values and principles that characterize who we are and how we work. It's time to join our world-class team, if the following attributes reflect your desire to contribute: Innovation - Cambrex employees have a strong desire to excel and apply their skills in innovative ways to meet the demands of an ever-changing business environment. Experience - Cambrex employees provide knowledge-based solutions and are empowered to make appropriate decisions, and demonstrate a commitment to quality in everything they do. Performance - Cambrex is an organization that appreciates and rewards, efficient, reliable performance, meets goals and objectives, and delivers the Cambrex promise to bring value to our customers and investors with uncompromising integrity and ethics.
Job Description
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.
Job Responsibilities
Responsibilities include, but are not limited to:
- 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, Production, Pilot Plant, 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
Job Qualifications
- BS Chemical Engineering
- 2 or more years of experience in API manufacturing and/or pilot plant environment highly preferred
- 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
Key Words
- Validation
- cGMP
- Chemical Engineering
- API Manufacturing
- Validated Systems
Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the 'Arthur I. Mendolia Scholarship Program.' Limited relocation offereed. Post offer physical and drug screen are required.
Thank you for your interest in Cambrex Charles City!
Agencies should not forward resumes to Cambrex through this source. Please contact Human Resources directly for consideration. Cambrex will not be responsible for any fees arising from the use of resumes through this source.
Equal Opportunity Employer M/F/D/V.
