Req #: 1800062B_en
Location: Thetford, ENG UK
Job Category: Engineering
Date Posted: 3/14/2018 12:49:05 PM
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anaesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
This role is for a Validation Engineer within a team that design and perform validation activities associated with new installation projects (Equipment / Facilities / Utilities / Systems), to the existing manufacturing process and manufacturing of Intravenous products at the Thetford plant.
The Validation Engineer function will work within one of six areas in a stream approach:
Equipment / Process systems
HVAC & Cleanroom systemsRole Responsibilities:
The Validation Stream Leads are expected to be the primary contact and validation subject matter experts (SME) for their particular field. They are also the owners of the validated state pertaining to their streams
Be able to will be able to interact and cover, at times, within streams other than their own
Authoring, executing and reporting validation activities within the framework of cGMP – Annex 11 & 15 and in compliance with Baxter Global QMS requirements
Manage multiple validation objects, liaising with the project team and all associated departments on site relating to the validation objects and work is completed in a timely manner.
Good working knowledge of Validation requirements for Equipment / Facilities / Utilities including associated control systems
Working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.