Production Engineer

Cambrex Corp.; Charles City, Northern (IA, KY); Hybrid; USD 65,000 - 85,000; Full time

Job summary

Cambrex Corp. in Charles City, IA, is seeking a Production Engineer to serve as an operations technical expert for API and bulk intermediate manufacturing from development through piloting and commercial production.

You will write batch records, initiate SOPs, review docs, troubleshoot equipment, support process transfers, and maintain IQ/OQ/PQ protocols while ensuring cGMP compliance and safety. BS in Chemical Engineering with 1–3 years in manufacturing preferred; knowledge of cGMP and chemical

Qualifications

• cGMP familiarity and related regulatory awareness.
• General knowledge of chemical operations equipment and manufacturing processes.

Responsibilities

• Write batch and cleaning records for commercial products and revisions as needed.
• Initiate SOPs, investigations, deviations, and CAPAs for production operations and products.
• Review and approve documentation for Operations with technical expertise.
• Troubleshoot equipment and coordinate with maintenance for efficiency improvements.
• Assist process engineers and development teams with new process transfers.

Education

BS in Chemical Engineering

1–3 years manufacturing experience

Tools

cGMP knowledge

Equipment knowledge

Job description

Company Information

You Matter to Cambrex.

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, Cambrex offers 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.

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

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.

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.

Qualifications/Skills

• 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 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 / Affрcative 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.