Sr Process Engineering

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.

Responsibilities

• 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
• Lead small to medium projects under $5M
• Interface with cross-functional teams to meet project goals
• Stay current with industry best practices and technologies
• Select and apply appropriate technologies, designing equipment, and diagnosing process issues
• Make data-driven decisions using engineering principles
• Ensure impact to product quality, safety, reliability, and throughput
• Maintain regulatory compliance and validation requirements
• Troubleshoot factory floor issues and support capacity planning
• Manage impact to uptime, batch continuity, and manufacturing schedule
• Respond to urgency and severity of equipment failures
• Determine escalation thresholds
• Balance short-term mitigation versus long-term solutions

Requirements

• 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
• Able to work in fast-paced, cross-functional teams
• Strong planning, prioritization, and escalation judgment

Qualifications

• Combination of sedentary work and facility walkdowns
• Occasional ladder climbing
• Ability to lift up to 25 lbs
• Participation in 24/7 on-call rotation
• Infrequent travel up to approximately 25% during project activities

Benefits

At Takeda, we are committed to equitable pay for all employees and 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.

U.S. based employees may be eligible for short-term and/ or long-term incentives.

U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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.

Locations: Brooklyn Park, MN

Worker Type: Employee

Worker Sub-Type: Regular Time

Type: Full time

Job Exempt: Yes