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Sr Process Engineer

Takeda · Brooklyn Park, MN

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Level
Senior
Team
Process
Base pay
$90k–$141k
Travel
25%
Degree
Required
Industry
Pharma & life sciences
Posted
30+ days ago

The role in 30 seconds

A senior process role at Takeda (pharma & life sciences) in Brooklyn Park, MN. Engineer-in-Training (EIT) or Professional Engineer license preferred.

They ask for
degree required
Tools it names
FDA / GMP, Validation (IQ/OQ/PQ), PLC, Automation, Capacity planning
Base pay
$90k–$141k
Day to day
some off-shift / weekend coverage · about 25% travel

Read from the posting. The full description is below.

At a glance

Off-shift / weekend coverageLifts up to 25 lbs

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Process team at Takeda

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Is the work mostly new product launches or sustaining existing lines?
    • How much time do you spend on the floor versus at a desk?
    • How does off-shift and weekend coverage work?
    • The posting says about 25% travel. Between which sites?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

About the role

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

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

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. In this role, you may:

  • ✓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

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.

For information about our benefits, please click here .

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

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Job Description

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

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

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

For Location

Brooklyn Park, MN

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