Posted to MedZilla on 7/21/2019


Takeda Pharmaceuticals

US-IL, Validation Associate III SR0036362-MZ


 
 

This position is in the Validation Engineering organization at the Round Lake, IL Takeda facility, 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.

DESCRIPTION / ESSENTIAL JOB FUNCTIONS:

  • Subject Matter Expertise on Computer System Validation/Automation 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
    • Temperature Mapping
    • Validation Maintenance
  • Provide validation support in deviation investigations and change control.
  • Contribute to regulatory filings, inspections and responses.
  • 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.
  • Primary subject matter expert in audits and regulatory agency inspections.
  • 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.

REQUIRED SKILLS AND EXPERIENCE-

QUALIFICATIONS:

  • BA or BS preferably in the Life Sciences/Engineering or other job-related discipline.
  • Minimum of 7 years validation experience, including designing, authoring, executing, and coordinating protocols. Validation within a pharmaceutical, biotech or related industry is highly preferred.
  • 4+ years of experience with CSV/Automation validation role. Proficient in system and software validation engineering processes, risk management, software V&V methodologies.
  • Ability to Lead cross-functional teams drawing on past Project Management 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: Automation, Validation, Documentation, PLC, SCADA, OSI PI, Pharmaceutical, Biotech, Systems, Batch, Protocols, Project Management, Deviations, Quality, Compliance, Risk Assessments, cGMP, GMP, Master Validation Plans, Qualification, Commissioning, QA.

PHYSICAL DEMANDS:

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.

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

May be required to work weekends, evenings, off-hours.

WORKING 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.
  • Make-up, jewelry, contact lenses, nail polish and artificial fingernails ARE PROHIBITED in the manufacturing environment.
  • May work in a colder or wet environment.
  • Must be able to work multiple shifts, including weekends as duties may require as directed.
  • May be required to work in a confined area.
  • Will be exposed to Clean Room and cool/hot storage conditions.

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 - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.


Please visit our website at takedajobs.com

 
 


* If a direct employer requests that you go to their web site and complete your application there in order to be
  considered, please do so. Applications for all positions are subject to each employer's specific requirements.