Posted to MedZilla on 5/20/2019

Takeda Pharmaceuticals

US-GA, Validation Engineer SR0035244-MZ


This position supports site projects, technical transfers, and ongoing validation maintenance. Primarily responsible for the design, authorship, and execution of commissioning, qualification and/or validation studies for the any or more of the following major disciplines:

  • Facilities, Utilities, and Equipment (FUE) qualification
  • Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems
  • Computerized systems validation
  • Cleaning validation
  • Sterilization validation
  • Process validation

Provides technical subject matter expert (SME) support to change controls, investigations, deviations, and CAPAs. Develops and executes protocols and summarizes results. Individual must work on simple to moderate assignments and follow detailed instructions, providing appropriate level of communication to management and stakeholders.


  • Independently designs, authors, executes and summarizes commissioning, qualification and/or validation studies. Partners with SMEs to ensure smooth and efficient execution of testing strategies.
  • Collaboratively conducts risk and impact assessments.
  • Supports development and review of standard operating procedures (SOP) and validation assessments.
  • Interfaces with customers on technical issues, project timeline, and validation support.
  • Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
  • Calculation and interpretation of data for commissioning, qualification and/or validation studies.
  • Participates in audits and regulatory agency inspections as a representative of the Engineering Validation team, as required.
  • Supports development of best demonstrated validation practices within the validation department, based on current industry practices and guidelines.
  • Serves on Tier 1 work stream teams, as required.

Education and Experience Requirements

  • Four-year college degree in engineering or science related curriculum required.
  • 1-5 years of relevant experience in a GMP regulated environment.
  • At least 2 years of commissioning, qualification and validation (CQV) desired.
  • Validation and/or system experience in the following applicable areas:
    • Sterilization and aseptic processing validation.
    • Cleaning validation of manufacturing equipment.
    • Process and utility systems validation, temperature mapping, manufacturing equipment commissioning and qualification.
  • Technical understanding and experience of automation platforms, such as DeltaV, Honeywell, Rockwell PLC, Siemens XFP.

Key Skills, Abilities, and Competencies

  • Excellent communication and attention to detail skills.
  • Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
  • Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
  • Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments.
  • Must be able to solve routine problems with assistance.

Complexity and Problem Solving

  • Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into manageable activities.
  • Knowledge of basic principles in various engineering disciplines.

Internal and External Contacts

  • Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation in support of execution activities.
  • Interaction with project managers for schedule adherence.

Other Job Requirements

  • May be required to work weekends, evenings, off-hours, extended periods of time.
  • Occasionally, may be required to lift up to 50 pounds, and be able to walk, stand, reach and stoop.
  • Needs to be able to gown and operate in an environment requiring gowning.
  • Up to 5% travel expected.

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.

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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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