Posted to MedZilla on 8/23/2019

Takeda Pharmaceuticals

US-MA, Validation Maintenance Manager SR0033147-MZ


Primary Duties

The individual will be responsible for supervising staff at the Lexington facility. Technical duties include setting validation strategy, adhering to domestic and international GMP regulations, incorporating continuous improvements into validation activities and policies, and participate in regulatory inspections. Leadership duties include developing strategy, leading change and motivating and developing personnel.

Periodic travel may be required for business meetings with contract manufacturers, peers / colleagues, vendors/contractors, and to stay current with professional development opportunities.

Routine local travel to Takeda sites.


Varies, 30-80%

Develop, maintain, and deploy drug product validation policies and practices in the following areas:

  • Facilities
  • Equipment
  • Shipping / Cold Chain
  • Process
  • Cleaning
  • Steaming / Autoclave
  • Computer Systems
  • Plant Automation
  • Validation Maintenance
  • Validation document control and archival program
  • Develop and assess the following Quality System elements for Validation:

  • Quality Risk Management program
  • CAPAs
  • Change Controls
  • Deviations
  • GMP Investigations


Develop, mentor, and coach staff.

Identify opportunities for continuous improvements, deploy best practices, pro-actively update validation programs to reflect current regulations and trends.

Varies, 10 - 20%

Participate and lead partner audits and regulatory agency inspections for Validation.

Author and review responses to inspection observations and agency questions.

Author and review sections of regulatory filings and annual product quality reviews.

Education and Experience Requirements

Minimum requirements include a Bachelor's degree in a technical, preferably an engineering or biological science discipline and 8-10 years pharmaceutical and/or biopharmaceutical industry experience. An advanced degree or additional industry certification is a plus.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law -

EEO is the Law Supplement -

Pay Transparency Policy -

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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