About the role:

You will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification / validation, and final report documents. You will be responsible for assess, qualify and validate equipment, critical systems (utilities), facilities, computer system, and cleaning, as applicable. Primary tasks include development of protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans. Responsibilities will consist of both initial validation efforts and revalidation.

Additionally, investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented. Final documents are archived and may be included in or support regulatory submissions, and made available during internal and external regulatory/compliance audits.

This position will provide interpretation of regulatory requirements.

You will work in cooperation with the manufacturing departments, Engineering, Regulatory, QC, and Quality Operations on a daily basis.

How you will contribute:

Responsibilities:

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

• Perform a variety of projects in several areas at the same time to support manufacturing and engineering.

• Responsible for planning, scheduling, and leading validation assignments. Must demonstrate planning and coordination.

• Review and change control requests with potential impact to validated state of validation elements, as applicable.

• Lead and interface with 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 accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.

• Write protocols and reports, execute validation documents regarding acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1).

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

• Utilize Quality-Engineering tools to problem solve/troubleshoot and assist in risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC).

• Use validation test equipment, such as, Kaye Validator and Ellabs loggers to support validation activities.

What you bring to Takeda:

Required: Bachelor’s degree in engineering discipline required. Chemical, Mechanical, Electrical Engineering Degree. 3+ years of related experience. Some leadership experience preferred for supervisory roles.

Desired: Experience in manufacturing processes and control systems, cleaning processes, process equipment, facilities and critical support systems.

Prior experience interacting with the FDA and other regulatory agencies.

• Must have experience, proficiency, and leadership in pharmaceutical/biotech validation elements, including the writing and implementing of protocols and standard operating procedures.

• Must be proficient in more than one validation element.

• Must have a comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and Technical Service experience.

• Must display a solid technical understanding of the validation element principles and scheduling a series of project technical and project management overviews.

• Must be able to lift, push, pull and carry up to 25 lbs.

• In general, you will have a combination of sedentary work and walking around observing conditions in the facility.

• May work in construction or demolition areas

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. 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 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.

• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

Other Job Requirements

Travel may be required to other Takeda facilities to manage projects related to these facilities or interact with other validation colleagues and/or as part of professional development.

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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