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Senior Validation Engineer

Date: Nov 15, 2022

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

Company Info

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

The Senior Validation Engineer will be responsible to validate and maintain the validated state for equipment and processes in cGxP laboratories and manufacturing facility at the Teva site located in West Chester, PA. The Validation Engineer will contribute to the development of Validation Master Plans, Process Validation, Equipment Qualification, Periodic Review/Requalification Program, Cleaning Validation Plans and Computer Systems Validation Plans.  The role is responsible for assisting in the timely development, execution and approval of all validation programs and lifecycle documentation and to ensure completion of projects per schedule requirements. The Sr. Validation Engineer must have thorough knowledge of global regulatory requirements for validation, including ERES (Part 11 and Annex 11) and GAMP5 guidelines.  The incumbent will be skilled in data integrity, manufacturing and laboratory equipment qualification, and GCP, GLP and cGMP regulatory procedures.

The position will be based in West Chester, PA.  Occasional travel may be required.

JOB RESPONSIBILITIES:

  • Support all aspects of the Validation Life Cycle from design through operation and maintenance to retirement.Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.
    • Work closely with Process Development, Manufacturing, and Quality Control to generate and execute PPQ protocols/reports for large molecule manufacturing (Upstream and Downstream processes).
    • Responsible for generation and execution of Equipment Qualification documents.
    • Coordinate and supervise validation testing performed by vendors.
    • Represent validation in multi-disciplinary teams focused on commissioning, validation, and computerized system validation. 
    • Support the Periodic Review’s and revalidation program.
    • Ensure site alignment with corporate standards and cGxP guidelines.
  • Author and revise standard operating procedures within the electronic documentation management system.
  • Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.  Independently contributes to development and process improvements of site validation standards.
  • Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives.
  • Work with QA and subject matter experts to initiate and implement corrective and preventive actions.
  • Support continuous improvement projects and activities.
  • Ensures training is up to date; provides training for validation contractors.
     

Qualifications

REQUIRED QUALIFICATIONS:

  • 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 4 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 QUALIFICATIONS:

  • Experience in process validation and continued process verification
  • At least 5 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

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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.


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