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Quality/Validation Engineer IV

Company: Allergan
Location: Campbell
Posted on: April 19, 2019

Job Description:

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infectivetherapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.Position OverviewThis is a key quality role reporting to the Site Quality Head. This position interacts with Validation, Engineering, Facilities, Quality Control, Manufacturing, Global Pharmaceutical Technology and Corporate groups. Main Areas of Responsibilities:Leading project engineering aspects related to the commissioning and validation of new laboratory systems and associated projects.Representing Quality in site utilities, equipment, and laboratory systems projects. Review and approve the scope of the projectReview and approve the change controls associated with the projectReview and approve all project lifecycle documentation including commissioning and validation packagesAble to review and make quality decisions on utilities/equipment/systems drawingsRelease new utilities, equipment and laboratory systems for GMP use.Managing and administrating the BSL plant quality systems including CAPA, deviation, change control, OOS, complaint, and work order systems. Supporting any plant or corporate driven initiatives to enhance these systems. Responsible for assessing and approving quality system documentation (all activities relating to the control, distribution, maintenance and closure of GMP Quality documentation.) Present and defend Quality records and data packages during FDA and Ministry of Health inspections. Requirements:Six (6) years of related Quality/Engineering experience is required. Three (3) years experience in managing and/or coordinating projects.Ability to establish and maintain electronic database. (i.e. deviation, change control, training documents, etc.).Ability to work in a Windows computer environment.Experience in Biotech or a Biopharmaceutical environment is highly desired.Strong user of excel or statistical programs.A thorough understanding of cGMP regulations and experiences in regulatory inspection is required.A General knowledge of Engineering codes and standards.Education BS degree in Engineering, Statistics, or Science degree from an accredited institution, Graduate degree is preferred.

Keywords: Allergan, San Francisco , Quality/Validation Engineer IV, Engineering , Campbell, California

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