Validation Engineer I

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

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

This role will execute validation activities to ensure completion of projects per schedule requirements

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.

The position is based in West Chester, PA. Occasional travel to other global Teva or vendor sites may be required.

Essential Duties & Responsibilities:

• Support all aspects of the Validation Life Cycle from design through operation and retirement.
• Responsible for authoring and execution of site Validation documentation (i.e. qualification protocols, summary reports, risk assessments, and periodic reviews)
• Perform temperature mapping studies for controlled temperature units (refrigerators, freezers, stability chambers, and walk-ins)
• Ensure vendor protocols are complete and accurate, assist vendor with issue resolution and validation deviation reporting
• Support revalidation program
• Represent Validation in multi-disciplinary teams focused on production and laboratory equipment and activities (i.e. commissioning, validation, and computerized system validation)
• Create and update Validation standard operating procedures
• Contribute to site alignment with corporate standards and cGMP guidelines
• Technically independent and maintains up-to-date knowledge of Validation standards and regulatory compliance requirements
• Work with subject matter experts to implement and/optimize key validation and quality initiatives at Teva Biologics
• Work with QA/Manufacturing group members to initiate Deviations and implement corrective and preventive actions
• Support internal and external audits and assessments
• Support continuous improvement projects and activities
• Ensure training is up to date

Qualifications

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

PREFERRED QUALIFICATIONS:

• Knowledge of 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, CIP, and cleaning verification
• Cooperative, independent, critical thinking, multi-tasking and detail oriented
• Excellent oral and written communication skills
• Validation experience in Biopharmaceutical products or combination of Validation and Engineering/Commissioning experience.

Function

Sub Function

Reports To

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