Production Engineer

Cambrex•Charles City, IA

14h

About The Position

The Production Engineer will be a Operations technical expert and 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.

Requirements

Knowledge of and/or direct experience in a cGMP environment is preferred
General knowledge of chemical operations equipment and manufacturing operations
BS in Chemical Engineering or similar field, plus 1 – 3 years of experience in manufacturing environment, preferably in pharmaceutical manufacture; or equivalent education/experience
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.
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.

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.
Troubleshoot equipment and coordinate with maintenance to monitor equipment for efficiency improvement.
Assist Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter.
Work 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 their assigned area workcenter.
Generate 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.
Train Operators or Technicians on equipment and process operations as needed to ensure safe and efficient manufacturing.
Additional job duties as assigned.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.