Validation Maintenance Manager (Hybrid) - Full-time / Part-time

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Job Title: Validation Maintenance Manager

Location: Lexington, MA

As the Validation Maintenance Manager, you will provide leadership to the Validation Maintenance Program for annual requalification of GxP manufacturing equipment used for commercial production, including developing validation strategy to the site and global projects. You will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification / validation, and final report documents. You will report to the Engineering Services Lead.

• Assess, qualify and validate equipment, critical systems (utilities), facilities, computerized systems, cleaning and sterilization processes.

• Coordinate with manufacturing and production schedules to access equipment to perform requalification on performance, cleaning or periodic reviews.

• Improve and adapt the Validation Maintenance Program processes to meet demands in the manufacturing facility by building partnerships across departments.

• Lead and represent the respective validation elements to determine validation strategy and system validation requirements based on concepts of life cycle to meet regulatory guidelines and industry standards.

• Develop protocols, coordination of validation activities, qualification/validation execution, preparing final reports and assembly of final validation packages; generation of project plans consisting of both initial validation efforts and revalidation.

• Write protocols and reports, and interpret 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).

• Plan, and schedule validation assignments and lead the validation team to prepare protocols and material for each activity. Guide peers in Validation and Engineering Departments to use statistically based Quality Engineering approaches in project, test plans and in analysis of test results.

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

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

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

• Support the investigation and closure of non-conformances/events, corrective actions and preventative actions.

• Participate in internal or external audits to support closure of observations and audit items. Assist with regulatory agency inspections and present validation strategy and protocols.

• Supervise validation personnel, contractors and outside vendors to meet project timelines, goals and milestones. Monitor and report validation costs including capital and expenses.

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

• Use KNEAT to develop, review and approve protocols.

• Typically requires BA or BS degree preferably in the engineering or science field.

• Must have experience leading a team and project management skills.

• Prior experience with manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process equipment, facilities and GMP critical support systems is required.

• Prior experience interacting with the FDA and other regulatory agencies .

• Proficiency and leadership in pharmaceutical/biotech validation elements, which includes the writing and executing of protocols and standard operating procedures.

• Expert knowledge of GMPs, FDA and EU guidelines/requirements, is required. Must be considered a proficient Subject Matter Expert (SME) in all validation elements.

• Understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant standard operating procedure curriculum, routine project procedures, and project management.

• Can analyze, plan, and implement resolutions to technical problems and familiarity with auditing techniques, interpreting regulations and quality systems.

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 and climb up into large processing tanks.

• Will work in Cleanrooms, including cold/hot storage conditions.

• 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.

• Will work mostly in office environment with requirements to work in manufacturing and support areas.

• Must have the ability to work in confined spaces (e.g. attic space, engine rooms and tanks).

• 20% travel may be required

• This is a hybrid role with a three day onsite requirement and must live within a commutable distance to Lexington, MA.

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.

#GMSGQ #ZR1 #LI-MA1

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.