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Validation Engineer III

4 months ago

West Chester, United States Teva Pharmaceuticals Full time
Who we are

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

The Validation Engineer III is responsible for ensuring the timely development, execution and approval of all validation programs and lifecycle documentation, (i.e. SOPs, Change Controls, CAPAs, Deviations), ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices.

The Validation Engineer III will lead, organize, and execute Validation activities to ensure completion of projects per schedule requirements. Also, contribute to the development of Validation Master Plans, Cleaning Validation Plans, and Computer Systems Validation Plans.

*** 100% ON-SITE IN WEST CHESTER, PA *** (Occasional travel to other global Teva or vendor sites may be required.)

How you'll spend your day

  • Support all aspects of the Validation Life Cycle from design through operation and improvements, and the revalidation program.
  • Responsible for the preparation of site validation documentation (i.e. qualification protocols, validation master plans, risk assessments, and periodic reviews)
  • Perform reviews of Validation documentation (i.e. protocols, summary reports, risk assessments, periodic reviews, and vendor validation documentation and summary reports.)
  • Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation)
  • Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing.
  • Create, maintain, and review Validation SOPs and ensure site aligns with corporate standards and cGMP guidelines
  • Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions
  • Support internal/external audits and assessments and lead/support continuous improvement projects and activities.
  • Provide support and training for Validation team members
  • Attend regular/recurring meetings to support the production facility during campaigns and provide project status reports to Management
Your experience and qualifications

Required:
  • Bachelor's degree or equivalent experience in life science, engineering or related discipline.
Preferred:
  • At least 8 years of Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience. (Knowledge in validation and quality compliance (cGMP/cGLP/ICH/FDA/USP/EU policies/guidelines.)

Additional Considerations:

The incumbent must be skilled in data integrity, manufacturing and laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures.

The Validation Engineer III must have thorough knowledge and experience with global regulatory requirements for Validation, including ERES (Part 11 and Annex 11) and current GAMP5 guidelines. The selected individual will be a key member of the R&D organization that owns and operates several cGxP laboratories and a manufacturing facility located at the West Chester campus.

Enjoy a more rewarding choice

We are strengthening and adding to our critical teams with great talent and capabilities: Teva, a global organization with a brand of evolving success. Be part of it

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, Paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva's Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.