Process Engineer

Role: Process Engineer MSAT / Tech Transfer
Location: Madison, Wisconsin (Onsite)

Employment Type: Contract

• Support the Manufacturing Science and Technology (MSAT) team as a technical expert for GMP biologics manufacturing.

• Lead and support technology transfer activities from process development and client-provided development information into manufacturing.

• Serve as a technical subject matter expert (SME) for manufacturing processes and develop Master Batch Records (MBRs).

• Support process scale-up activities and ensure successful transfer of processes into commercial manufacturing.

• Prepare and review deviation records, impact assessments, and other quality-related documentation.

• Apply Quality Management System (QMS) experience to support GMP compliance and manufacturing operations.

• Evaluate process development data and understand Quality Target Product Profile (QTPP) requirements.

• Support the design, development, and optimization of manufacturing processes.

• Collaborate closely with external clients and cross-functional teams in a CDMO environment.

• Provide technical expertise across upstream and downstream biologics manufacturing processes.

• Strong experience in MSAT, biologics manufacturing, and technology transfer.

• Hands-on experience with biologics drug substance manufacturing.

• Experience transferring processes from process development to GMP manufacturing.

• Strong knowledge of upstream and downstream manufacturing processes.

• Experience with process scale-up and manufacturing process design.

• Ability to develop and review Master Batch Records (MBRs).

• Experience handling deviations, impact assessments, and QMS documentation.

• Understanding of Quality Target Product Profile (QTPP) and GMP requirements.

• Strong technical problem-solving and process development skills.

• Excellent communication and interpersonal skills, with the ability to interact effectively with external clients.

• Ability to work independently with minimal technical training.

Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.