Validation Engineer I

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 Validation Engineer is responsible for assisting in the timely development, execution and approval of all validation programs and documentation, ensuring compliance with in-house specifications, standards and procedures, and implementing industry best practices. This role will organize all validation activities to ensure completion of projects per schedule requirements. 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 retirement.
• Responsible for the preparation and execution of site validation documentation such as qualification protocols, risk assessments, summary reports and periodic reviews.
• Ensure validation testing performed by vendors is complete and accurate; work with vendors for issue resolution and validation deviation reporting.
• Execute temperature mapping studies for refrigerators, freezers, stability chambers, and cold rooms.
• Represent validation in multi-disciplinary teams focused on GxP laboratory and manufacturing equipment activities (working with commissioning, validation, and computerized system validation).
• Support the revalidation program.
• Ensure site alignment with corporate standards and cGMP guidelines.
• Upkeep of validation standard operating procedures.  Authoring and revising procedures within the electronic documentation management system.
• Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.  
• Work independently and/or with subject matter experts to implement and/optimize key validation and quality initiatives at Teva Biologics.
• Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions.
• Support continuous improvement projects and activities.
• Regular reporting to QA and Manufacturing Management via updates and presentations.
• Ensures training is up to date.
   

Qualifications

REQUIRED QUALIFICATIONS:

• BS or equivalent combination of education and experience in life science or engineering

PREFERRED QUALIFICATIONS: 

• Knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines) 
• Validation experience with production equipment, support equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, SIP/CIP, or cleaning verification 
• at least 1 years Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience
• Cooperative, independent, critical thinking, multi-tasking and detail oriented
• Excellent oral and written communication skills

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.