Sr Process Engineer

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

Job Description

About the Role

• Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)
• Ensure systems remain in a qualified state.
• Act as technical owner for system lifecycle including design, installation, qualification, production support, deviation resolution, maintenance, and decommissioning.
• Monitor system reliability and performance.
• Develop and implement engineering solutions to complex problems.
• Lead programs related to system qualification, asset management, project execution, and Good Engineering Practices.
• Support development of site staff on technical and procedural topics.

How you will contribute

• Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications.
• Implement system modifications under cGMP change control.
• Develop and execute FAT, commissioning protocols, and qualification protocols.
• Develop calibration and preventative maintenance plans.
• Lead deviation investigations and implement corrective and preventative actions.
• Participate in capital planning, spending, and tracking.
• Serve as project manager on small to medium projects under $5M.
• Interface with cross-functional teams to meet project goals.
• Stay current with industry best practices and technologies.
• Complete required training within timeframe.
• Selecting technologies, designing equipment, and diagnosing process issues.
• Making data-driven decisions using engineering principles.
• Ensuring impact to product quality, safety, reliability, and throughput.
• Maintaining regulatory compliance and validation requirements.
• Troubleshooting factory floor issues and supporting capacity planning.
• Managing impact to uptime, batch continuity, and manufacturing schedule.
• Responding to urgency and severity of equipment failures.
• Determining escalation thresholds.
• Balancing short-term mitigation versus long-term solutions.
• Perform other duties as assigned.

What you bring to Takeda

• Bachelor’s degree in Engineering
• 3 or more years of relevant experience
• Experience in pharmaceutical or biotechnology manufacturing environment
• Engineer-in-Training (EIT) or Professional Engineer license preferred
• Demonstrated track record supporting process operations and projects in an FDA-regulated environment
• Knowledge of engineering principles including fluid mechanics, heat transfer, thermodynamics, and mass transfer
• Experience applying project management methodologies
• Understanding of commissioning and qualification protocol development
• Direct experience with systems such as bioreactors, centrifugation, chromatography, tangential flow filtration, CIP, autoclaves, clean utilities, and HVAC.
• Familiarity with instrumentation and sensing technologies in pharmaceutical manufacturing
• Experience with regulatory requirements and GMP environments
• Experience supporting large capital projects
• Familiarity with batch control systems, data historians, SQL, and scripting (preferred)
• Knowledge of automation, PLCs, power systems, and controls (desirable)
• Proficient in MS Office (Word, Excel, PowerPoint) and MS Project
• Ability to work in fast-paced, cross-functional teams
• Strong planning, prioritization, and escalation judgment

Important Considerations

• At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product.
• Combination of sedentary work and facility walkdowns
• Occasional ladder climbing
• Ability to lift up to 25 lbs.
• Participation in 24/7 on-call rotation
• Use of PPE and clean room garments as required
• Infrequent travel up to approximately 25% during project activities.

More about us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. #GMSGQ #ZR1 #LI-Onsite

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Brooklyn Park, MN U.S. Base Salary Range: $89,900.00 - $141,240.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Takeda is an equal opportunity employer.

Locations

Locations Brooklyn Park, MN Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes