Process Engineer - GMP Biotech Systems

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

Job summary

Takeda in Brooklyn Park, MN is seeking an Engineering subject matter expert for designated biopharma process areas (cell culture, harvest, purification, CIP, or clean utilities). You will own the system lifecycle, from design and installation through qualification, maintenance, deviations, and decommissioning, ensuring systems stay qualified and reliable.

You will develop PFDs, P&IDs, specifications, FATs, and qualification protocols; implement changes via cgmp change control; lead CAPAs and

Qualifications

• Bachelor's degree in Engineering is required.
• Chemical Engineering degree is preferred.
• Engineer-in-Training (EIT) or PE license is preferred.
• Experience in FDA-regulated manufacturing with cGMP is preferred.

Responsibilities

• Serve as engineering SME for a chosen process area and own system lifecycle.
• Develop PFDs, P&IDs, System Specifications, and Functional Specifications.
• Implement changes through cGMP change control processes.
• Develop FATs, commissioning, and qualification protocols.
• Create robust calibration and preventive maintenance strategies.
• Lead investigations and CAPAs for deviations.
• Stay current with biopharma industry best practices.
• May serve as Project Manager on small capital projects (<$1M).
• Collaborate with cross-functional teams to execute initiatives.
• Complete required training within timelines.
• Perform other duties as assigned.

Skills

Cross-functional collaboration

Planning & organization

Communication skills

Education

Bachelor's degree in Engineering

Chemical Engineering degree preferred

EIT/PE preferred

FDA-regulated manufacturing experience preferred

Tools

Microsoft Office

Microsoft Project

Job description

Takeda in Brooklyn Park, MN is seeking an Engineering subject matter expert for designated biopharma process areas (cell culture, harvest, purification, CIP, or clean utilities). You will own the system lifecycle, from design and installation through qualification, maintenance, deviations, and decommissioning, ensuring systems stay qualified and reliable.

You will develop PFDs, P&IDs, specifications, FATs, and qualification protocols; implement changes via cgmp change control; lead CAPAs and