Sr. Production Engineer

Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, we offer a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid‑phase peptide synthesis, solid‑state science, material characterization, and highly potent APIs. We’re committed to 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, enjoy new experiences, and strengthen connections with coworkers and the community. The role offers competitive benefits including healthcare, life insurance, retirement planning, and more. Job Overview The Production Engineer will be an Operations technical expert responsible for reviewing documentation for Operations to implement projects for the manufacture of APIs, bulk intermediates, and other products from development through piloting and/or commercial production. Responsibilities Writing batch records and cleaning records for commercial products or simple revisions, campaign reports, as needed to support production operations. Initiate SOPs and investigations/deviation reports/CAPAs for production operations and commercial products. Reviewing and approving documentation (batch records, cleaning records, supplements, etc.) for Operations as the area technical expert. Troubleshooting equipment and coordinating with maintenance to monitor equipment for efficiency improvement. Assisting Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter. Working with Validation Engineering and Maintenance departments on developing and maintaining IQ, OQ, and PQ documents and protocols; ownership of equipment and facility change controls in the assigned area workcenter. Generating product setups and cleaning memos as needed. Troubleshooting, investigating process problems and deviations, and preparing appropriate reports on findings. Participating in HAZOPs and providing guidance on corrective actions when needed. Completing CAPAs and audit action items as assigned. Training operators or technicians on equipment and process operations to ensure safe and efficient manufacturing. Performing additional job duties as assigned. Qualifications Knowledge of and/or direct experience in a cGMP environment is preferred. General knowledge of chemical operations equipment and manufacturing operations. Education, Experience & Licensing Requirements BS in Chemical Engineering or a related field, plus 1–3 years of experience in a manufacturing environment, preferably pharmaceutical manufacture; or equivalent education and experience. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on successful completion of a comprehensive pre‑employment screen, which may include 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 from further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affiliation 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. #J-18808-Ljbffr Cambrex