Biopharma Process Engineer: GMP Systems Lifecycle Lead

Takeda Pharmaceutical Co.; Brooklyn Park (MN); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda is seeking an Engineering SME for a defined process area (cell culture, harvest, purification, CIP, or clean utilities) to keep systems in a qualified state and own the lifecycle from design to decommissioning.

You will develop PFDs, P&IDs, system specs, FAT and qualification protocols, and support cGMP change control with cross-functional teams. A Bachelor's in Engineering is required; Chemical Engineering degree is preferred; EIT/PE is a plus.

Qualifications

• Engineering degree required with increasing responsibilities.
• Experience in pharmaceutical/biotech manufacturing is preferred.
• FDA-regulated industry and cGMP experience is highly desirable.
• Familiarity with bioprocess equipment and automation is valued.

Responsibilities

• Develop PFDs, P&IDs, system specifications and functional specs.
• Implement changes through cGMP change control processes.
• Develop FAT, commissioning and qualification protocols.
• Create calibration and preventive maintenance strategies.
• Lead deviations investigations and CAPA implementations.
• Collaborate with cross-functional teams on engineering initiatives.

Skills

Process engineering

cGMP knowledge

Cross-functional teamwork

Project coordination

Education

Bachelor's degree in Engineering

Chemical Engineering degree preferred

EIT/PE certification preferred

Tools

PLC programming

Instrumentation

Microsoft Office

Microsoft Project

Job description

Takeda is seeking an Engineering SME for a defined process area (cell culture, harvest, purification, CIP, or clean utilities) to keep systems in a qualified state and own the lifecycle from design to decommissioning.

You will develop PFDs, P&IDs, system specs, FAT and qualification protocols, and support cGMP change control with cross-functional teams. A Bachelor's in Engineering is required; Chemical Engineering degree is preferred; EIT/PE is a plus.