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Job Description

About the role:

As the Engineering Services Lead, you will report into the Head of Site Engineering for MA Bio Ops. In this role you will:

• Empower, develop, and support staff members to ensure validation requirements are applied as “fit for purpose” for the manufacture of drug substance while meeting Regulatory, Quality, Capacity and EHS requirements.

• Responsible for oversight of the validation maintenance and project activities at the MBO site that includes qualification of equipment, critical systems/utilities, computerized systems, facilities, cleaning and sterilization process qualifications.

• Provides leadership to validation disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#

• The incumbent is responsible to improve existing validation processes to ensure compliance while also driving efficiencies. Provide leadership to all validation related investigations

• Develop and implement strategies to drive efficiencies in cost and time within the validation maintenance and project activities.

How you will contribute:

• Leadership

  • Leadership expectations of this position include coaching and developing direct reports, ensuring adherence to performance management processes, and the implementation of departmental talent management and succession planning programs. Lead and inspire people while promoting a working culture that empowers and engages employees while stimulating a focus on quality, continuous improvement, collaboration, and innovation.

  • Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.

  • Integral member of the Site Engineering Leadership Team and works in collaboration with the team to drive Site Engineering strategic objectives.

  • In collaboration with the Engineering Leadership Team, lead the transformation of Engineering into a best-in-class organization that is fit for the future.

• Organization:

  • Manage, identify, hire, and develop team to support validation activities. Manage continued growth, development, and retention of the team.

  • Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills.

  • Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation. Emphasis is on ensuring validation activities meet regulatory guidelines and industry standards.

• Technical

  • Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.

  • Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.

  • Identify gaps related to validation requirements and Global Validation procedures. Drive and close compliance gaps as they are identified.

  • Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.

  • Lead in the drafting and implementation of Global Validation procedures including initiatives for harmonization and streamlining efforts. Develop and implement new validation approaches as needed.

  • Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections.

• Projects

  • Supervise, as needed, other validation personnel, contractors and outside vendors to meet project timelines, goals and milestones.

  • Monitor and report validation costs including capital and cross-functional expenses.

  • Provide planning and scheduling support for validation projects. Responsible for defining validation scope of work, resources, and duration for projects to meet site-wide validation and budgetary goals.

  • Ability to present a course of action to management and project team using both written and verbal communication tools.

Minimum Requirements/Qualifications:

• Engineering degree or equivalent required with a specialization in Chemical, Biochemical, Mechanical or Industrial engineering preferred

• Minimum of 8 years of work experience in the pharmaceutical or related industry.

• 5 years of people leadership experience preferred.

• Proven engineering experience in a GMP environment and prior experience interacting with the FDA and other regulatory agencies preferred

• Thorough knowledge of Validation processes in Pharmaceutical Manufacturing and experience in manufacturing processes, control systems, cleaning processes, process equipment, facilities, temperature-controlled units and critical support systems preferred.

• Strong interpersonal skills and communication abilities. Able to manage up and across the organization

• Sound business acumen and ability to align engineering services with business needs and within financial constraints.

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

• Paid time off for vacation, sick leave, and volunteering

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional development 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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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

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.

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