Process Engineering Senior

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Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or utilities systems)

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

Develop engineering deliverables including Process Flow Diagrams, P&IDs, System Specifications, and Functional Specifications

Develop and execute FAT, commissioning protocols, and qualification protocols

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

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

Balancing short-term mitigation versus long-term solutions

Bachelor’s degree in Engineering

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

Strong planning, prioritization, and escalation judgment

Combination of sedentary work and facility walkdowns

Participation in 24/7 on-call rotation

Infrequent travel up to approximately 25% during project activities

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

Full time