The Associate Director, Process Engineering, reports to the Head of Site Engineering at Takeda's Round Lake plant. You will manage the Process Engineering staff, projects and support. Establish engineering discipline and practices that support the operation of manufacturing while improving process functionality. Lead scope definition /clarification exercises to completely characterize process requirements. Responsible for all process and related functions including conceptual design, specifications, budgeting, scheduling, construction management, commissioning and start up, to ensure effective implementation. Will evaluate, provide recommendations, and implement manufacturing process efficiencies, including in areas of visual inspection, filling and packaging processes. Provide guidance and direction to employees and contractors to meet project and support schedules and financial goals while ensuring technical success.

How you will contribute:

• Coach, motivate, develop, recognize and mentor the process engineering staff, including senior level engineers and managers.

• Through coaching, direct others to resolve project issues based on own demonstrated success in solving difficult and complex problems.

• Assess manufacturing processes, including visual inspection, packaging, and aseptic seal-fill-seal processes, to deliver recommendations and process improvements to gain process efficiencies.

• Evaluate serialization, container closure integrity, and visual inspection processes to improve workstreams, efficiencies, and accuracy.

• Manage and forecast capital and expense budgets.

• Provide leadership to assess and provide guidance and risk assessments regarding requirements for redundancies to equipment, processes and systems.

• Responsible for assigning resources to support manufacturing operations, training initiatives and Process Engineering projects.

• Independently plans, schedules and leads cross-functional team in detailed phases of the engineering support work.

• Assess, analyze, advise, propose and direct improvements to deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department. 

• Review, analyze and direct capital and expense projects to achieve greater equipment and facility reliability, improve process performance and improve product quality.

• Establish, develop and drive Good Engineering Practices in all projects undertaken and support services provided.  Utilize standard methodologies that have been established for project and portfolio management as well as maintenance work order management.

• Participate in, facilitate and lead the harmonization and coordination of efforts between other teams such as Validation, Manufacturing, Facilities Engineering, Maintenance, Technical Services, R&D, EHS and Regulatory.

• Shall interface with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits, and shall be able to defend current practices to such agencies.

Minimum Requirements/Qualifications:

• Bachelor's degree in science, engineering, or other related technical field.

• Minimum of 8+ years of related experience.

• Minimum of 3+ years in a management role.

• Scope requires an in-depth knowledge of pharmaceutical or food industry process equipment related to process equipment, HVAC , purified water systems (R.O., WFI), and general working GMP knowledge of pharmaceutical manufacturing facilities and all major utilities

• Related experience in process design, engineering and process improvement.

• Extensive experience with flexible bag sealing, filling, and packaging equipment. 

• Serialization experience, especially with Systech systems. 

• Experience with container closure integrity and automated visual inspection.

• Continuous improvement mindset.

• Experience leading teams through site expansions.

• Sound industry knowledge, project proficiency, and autonomy expected.  May be considered a Subject Matter Expert (SME) in various disciplines.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous paid time off for vacation, sick leave, and volunteering

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional development and training opportunities

• Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.