Senior Process Engineer: GMP Systems & Capital Projects

USA - 3345 Takeda Manufacturing U.S.A., Inc; Brooklyn Park (MN); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda is seeking an Engineering Subject Matter Expert for our Brooklyn Park, MN site to own system lifecycles, qualification, and maintenance across process areas. You will lead projects up to $5M, collaborate with cross-functional teams, and ensure product quality, safety, and regulatory compliance.

This role requires a Bachelor’s in Engineering and 3+ years in a pharma/biotech environment, with knowledge of GMP, process equipment, and qualification protocols.

Qualifications

• Bachelor’s degree in Engineering required.
• 3+ years of relevant experience in pharma/biotech manufacturing.
• Experience in FDA-regulated environment and GMP environments.

Responsibilities

• Develop engineering deliverables including P&IDs, Process Flow Diagrams, System Specifications, and Functional Specifications.
• Implement system modifications under cGMP change control.
• Develop and execute FAT, commissioning protocols, and qualification protocols.
• Lead deviation investigations and corrective and preventative actions.
• Interface with cross-functional teams to meet project goals.
• Manage projects up to $5M in scope.
• Ensure regulatory compliance and validation requirements.

Skills

Engineering knowledge

Project management

Cross-functional collaboration

Data-driven decisions

Education

Bachelor’s degree in Engineering

Engineer-in-Training (EIT) or Professional Engineer license preferred

Tools

MS Project

SQL

Scripting

Job description

Takeda is seeking an Engineering Subject Matter Expert for our Brooklyn Park, MN site to own system lifecycles, qualification, and maintenance across process areas. You will lead projects up to $5M, collaborate with cross-functional teams, and ensure product quality, safety, and regulatory compliance.

This role requires a Bachelor’s in Engineering and 3+ years in a pharma/biotech environment, with knowledge of GMP, process equipment, and qualification protocols.