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Validation Engineer III

Date: Nov 13, 2022

Location: West Chester, US, 19380

Company: Teva Pharmaceuticals

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Job Description

 

DEPARTMENT: Biologics Operations Support Services (BOSS)

 

JOB RESPONSIBILITIES:

  1. Support all aspects of the Validation Life Cycle from design through operation and improvement as required for all Teva Biologics validation functions.
    1. Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.
    2. Coordinate and execute approved process validation, IQ, OQ and PQ protocols for the Biologics Manufacturing Facility (BMF), and GMP/GLP laboratories supporting large molecule testing
    3. Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing
    4. Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data
    5. Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting.
    6. Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation). 
    7. Support the revalidation program.
    8. Ensure site alignment with corporate standards and cGMP guidelines.
    9. Upkeep of validation standard operating procedures.  Authoring and revising procedures within the electronic documentation management system.
    10. Attends regular/recurring meetings to support the production facility during campaigns.
  2. Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.  Independently contributes to development of new site validation standards.
  3. Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives.
  4. Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions.
  5. Provides weekly and/or monthly project status reports to Management
  6. Represent BOSS in regulatory agency inspections as required.
  7. Support continuous improvement projects and activities.
  8. Regular reporting to QA and Manufacturing Management via updates and presentations.
  9. Attend design meetings, and factory acceptance tests at vendor sites.
  10. Attends meetings to provide validation input for new projects, and attends critical utility/environmental monitoring excursion team meetings.  
  11. Ensures training is up to date, provides training for validation contractors.
     

Qualifications

 

REQUIRED:

  • BS or equivalent experience in life science or engineering; knowledge in validation and quality compliance (cGMP/cGLP/ICH/FDA/USP/EU policies/guidelines) 
  • At least 6 years Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience
  • Experience of successful interfacing with Scientists, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation
  • Experience in analytical equipment qualification, manufacturing systems, and data integrity

 

PREFERRED:

  • Experience in process validation and continued process verification
  • At least 6 years Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience
  • Validation experience with production equipment, support equipment, utility systems, analytical lab equipment, computerized systems/automation, periodic reviews, cleaning and process validation 
     

Function

Sub Function

Reports To

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.

Teva Pharmaceuticals USA requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, however, Teva will consider requests for reasonable accommodations.


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