Process Engineering Team Lead

About the role:

The primary responsibility of this position is to lead the Process Engineering team responsible for supporting aseptic filling operations and cross-functional improvement initiatives. This role provides leadership, prioritization, technical direction, and oversight for the team’s work in aseptic filling, process optimization, deviation investigations, change management, improvement programs, CAPA implementation, and technical input for capital projects that impact filling operations.

How you will contribute:

• Lead the Process Engineering team responsible for supporting aseptic filling operations and cross-functional improvement initiatives.
• Provide leadership, prioritization, technical direction, and oversight for the team’s work.
• Assign, coordinate, and oversee team support for deviation investigations, change management activities, improvement programs, and CAPA implementation.
• Ensure the team provides timely technical support to Manufacturing, Quality, Maintenance, Reliability Engineering, and Supply Chain for process, component, and equipment issues affecting manufacturing performance and product quality.
• Lead team efforts to identify, prioritize, and implement process optimization opportunities that improve quality, compliance, reliability, yield, and operational efficiency.
• Provide technical direction and oversight for team contributions to capital projects that impact filling operations, including requirements, technical assessments, protocol support, validation execution, and operational readiness.
• Manage team priorities, resource allocation, performance expectations, and cross-functional alignment to ensure engineering commitments are delivered effectively
• Execute some projects covered by the Process Engineer Team.

What you bring to Takeda:

• B.S. in Engineering (preferably Chemical, Mechanical, or Electrical)
• Minimum 10+ years experience in pharmaceutical or food filling operations in an engineering role – aseptic filling or IV bag experience preferred
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint) and MS Project.
• Must have ability to author user and technical specifications, technical protocols and reports.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Must know how to effectively run projects, coordinate contractors, and direct the activities of technicians. Must have the ability to organize and present technical and project management overviews
• Must have good verbal/written communication skills, including creation and presentation of project proposals to senior management.
• PMP certification a plus
• Six sigma certification a plus

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection
• Must be able to, push, pull and carry up to 25 lb
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
• Indoor working conditions
• Will work around moving equipment and machinery.
• May be required to work in confined spaces/areas.

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.

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