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Validation Associate III

Round Lake, Illinois


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Validation Associate III

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Job ID SR0045576 Date posted 01/13/2020 Location Round Lake, Illinois

This position is in the Validation Engineering organization at an aseptic pharmaceutical manufacturing facility. The Validation Associate III will mostly work individually or as part of a team, executing medium to large scope validation projects to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. 


  • Subject Matter Expertise on Hardware/Software Validation and Data Integrity in compliance with regulatory and local requirements, and established procedures.
  • Also responsible for the design, authorship and execution of qualification and validation studies for the any or more of the following major disciplines:
    • Manufacturing equipment commissioning and qualification
  • Self-starter who can manage project resources to accomplish defined scope of work and company goals.
  • Must have proficiency in technical writing along with oral communication skills.
  • Reviews executed protocols for completeness, cGxP compliance and data acceptability.
  • Knowledge of current regulations for CSV and Data Integrity.
  • Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates.
  • Reviews executed protocols for completeness, cGxP compliance and data acceptability.
  • Other duties as required.


  • BA or BS or higher, preferably in the Life Sciences/Engineering or other job-related discipline.
  • Minimum of 7 years validation experience, including designing, authoring, executing, and coordinating validation protocols. Validation within a pharmaceutical, biotech or related industry is highly preferred.
  • 4+ years of experience with Hardware/Software validation role. Proficient in system and software validation engineering processes, risk management, software V&V methodologies, SCADA, PLCs.
  • Ability to Lead cross-functional teams drawing on past experience, autonomy expected.
  • This position requires a quality conscious, industrious individual who pays attention to detail and displays good work ethic.
  • Proactively and regularly communicates with team leader and members to update validation status in verbal and written form.

Keywords: PLC, SCADA, OSI PI, Pharmaceutical, Biotech, Systems, Batch, Protocols, IQ/OQ/PQ, Deviations, Quality, Compliance, Risk Assessments, cGMP, GMP, Master Validation Plans, Qualification, Commissioning, QA.


Occasionally, may be required to lift up-to 30 pounds, and be able to walk, stand, reach and stoop.

Ability to walk some distance 1-3 miles on occasion.

May be required to stand 3-6 hours during a work day.

Occasionally, required to work weekends, evenings, off-hours as may be required in a manufacturing environment.


  • Must be able to work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body when in controlled environments.

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.

Job ID SR0045576

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