Teva Pharmaceuticals Validation Engineer in West Chester, Pennsylvania
Date: May 17, 2018
Location: West Chester, Pennsylvania, US, 19380
Company: Teva Pharmaceutical Industries Ltd.
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!
The role is responsible for assisting in the timely development, execution and approval of all validation programs and documentation such as validation lifecycle documentation and quality records (e.g., SOPs, Change Controls, CAPAs, Deviations, etc.), 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 Validation Engineer must have thorough knowledge of global regulatory requirements for validation, including ERES (Part 11 and Annex 11) and current GAMP5 guidelines.
The role is responsible to support all aspects of the Validation Life Cycle from design through operation and maintenance. The role will prepare site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews. Coordinate and execute approved process validation, IQ, OQ and PQ protocols for a manufacturing production facility and GMP/GLP laboratories. Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing. Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data. Ensure validation testing performed by vendors is complete and accurate and work with vendors for issue resolution and validation deviation reporting. Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation).
Support the revalidation program. Ensure site alignment with corporate standards and cGMP guidelines. Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements. Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives.
REQUIRED QUALIFICATIONS :
BS or equivalent combination of education and experience in life science or engineering; knowledge in validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines)
Minimum 3 years of Equipment and/or Process Validation experience or combination of Validation and Engineering/Commissioning experience in the pharmaceutical industry required; preferably in biopharmaceutical products
Experience of successful interfacing with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation
Understanding of utility systems, process instrumentation, automation systems, and analytical equipment
Experience of establishing overarching, comprehensive and compliant life-cycle programs for validation of process equipment, automation and utilities
Able to review Algebraic, Geometric and Statistical calculations for data analysis
Excellent oral and written communication skills
PREFERRED QUALIFICATIONS :
5 or more years of related pharmaceutical Validation and Engineering/Commissioning experience
Validation experience with production equipment, support equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, SIP/CIP, and cleaning verification
Cooperative, independent, critical thinking, multi-tasking and detail oriented
In process of validation
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, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Philadelphia