1+ months

Validation Engineer

West Chester, PA 19380
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 role is responsible for assisting in the timely development, execution & approval of all validation programs and lifecycle documentation, e.g. SOPs, Change Controls, CAPAs, Deviations, ensuring compliance with in-house specifications, standards & procedures & implementing industry best practices. This role will organize validation activities to ensure completion of projects per schedule requirements.

 

  • The Validation Engineer must have thorough knowledge of global regulatory requirements for validation, including ERES (Part 11 and Annex 11) & current GAMP5 guidelines.
  • Support all aspects of the Validation Life Cycle from design through operation & maintenance to retirement.
  • Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments & periodic reviews.
  • Work closely w/ Process Development, Manufacturing, & Quality Control to generate & execute PPQ protocols for the production facility supporting large molecule testing.
  • Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing & Finished Product QC testing.
  • Ensure validation testing performed by vendors is complete & accurate; work w/ vendors for issue resolution & validation deviation reporting.
  • Represent validation in multi-disciplinary teams focused on production & laboratory equipment & activities (commissioning, validation & computerized system validation).
  • Support the revalidation program.
  • Ensure site alignment with corporate standards & cGxP guidelines.
  • Authoring & revising standard operating procedures within the electronic documentation management system.
  • Technically independent & maintains up-to-date knowledge of validation standards & regulatory compliance requirements.
  • Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives.
  • Work with QA & SME to initiate & implement corrective & preventive actions.
  • Support continuous improvement projects & activities.
  • Ensures training is up to date; provides training for validation contractors.
Qualifications

 


Required Qualifications:

  • Bachelor of Science degree in Life Science or Engineering
  • 3+ years Validation experience in Biopharmaceutical products or combination of Validation & Engineering/Commissioning experience
  • 3+ years of experience of successful interfacing with Scientists, Quality, Operations & Information Technology groups to develop requirements, establish programs & manage day-to-day operation
  • 3+ years of experience in process performance qualification, manufacturing systems, data integrity & analytical equipment

 

Preferred Qualifications:

  • Experience in process validation & continued process verification
  • 5+ years Validation experience in Biopharmaceutical products or combination of Validation & Engineering/Commissioning exp.

 

Function
Manufacturing
Sub Function
Technical Transfer
Reports To

Associate Director, R&D Unit

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.

Categories

Posted: 2020-06-19 Expires: 2020-09-03

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Validation Engineer

Teva Pharmaceuticals
West Chester, PA 19380

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