This position is in the Validation Engineering organization at Takeda in Round Lake, IL, an aseptic pharmaceutical manufacturing facility. The Validation Associate II will work individually or as part of a team, executing small to medium scope validation studies to ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus two or more validation disciplines related to Cleaning Validation of Manufacturing Equipment, Process Validation and Equipment Validation. The incumbent will be responsible for initiating and ensuring proper documentation within the scope of the validation. Expected to author and execute Validation Master Plans, Commissioning, Qualification and/or Validation studies in accordance with existing Corporate and Local Procedures.
DESCRIPTION / ESSENTIAL JOB FUNCTIONS:
- Define, plan and manage validation protocols while meeting applicable regulatory requirements.
- Able to generate cleaning development and validation protocol, cleaning assessments, summary reports, equipment Surface Area report, Grouping Strategy Report.
- Coordinates cleaning validation execution activities with all involved departments and trained personnel from operations, maintenance on Validation protocols.
- Able to apply risk-based approach for cleaning validation efforts.
- Review the URS, FS, DS and DR and Assure requirements traceability throughout the whole project validation file (from URS to PQ).
- Review the commissioning protocols and reports to ensure leveraging into qualification.
- Develop and execute test cases, identify defects and document corresponding deviations.
- Identify root-cause and follow-up to resolve deviations with thorough investigation.
- Execute and manage validation activities as defined in the project plan. Act independently with minimal supervision to execute validation studies.
- Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP).
- Interacts with customers that also include functional peer groups (System Owners, Manufacturing, QA) at various management levels to gain cooperation, foster collaboration and positively influence project outcomes.
- Capable of Leading cross-functional teams to timely completion of validation efforts.
- Must have proficiency in technical writing along with oral communication skills adequate to communicate with other team members.
- 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.
- Perform all other relevant duties as assigned.
REQUIRED SKILLS AND EXPERIENCE:
Prior experience with CIP skids and cleaning process development activities for tanks, fill lines/similar including parameters selection, cleaning agent selection, determining order of cleaning phases, troubleshooting, sampling and data analysis is desirable.
- BA or BS preferably in the Life Sciences/Engineering or other job-related discipline.
- 3 years validation experience, including designing, authoring, executing, and coordinating validation protocols. Validation within a pharmaceutical, biotech or related industry is highly preferred.
- Familiar with Quality Management and GxP Regulations.
- Knowledge of basic principles in various engineering disciplines as well as be experienced applying project management methodology.
- This position requires a quality conscious, industrious individual who pays attention to detail.
- 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.
- 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 and as directed on occasion.
- 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
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.