Validation Engineer II
Company: Renaissance LLC
Posted on: March 20, 2023
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.
This position is responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products.
Major job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, managing project timelines, and participating in cross functional teams.
--- Bachelor's Degree in Engineering, Life Sciences or related discipline, with a minimum of 3 years of relevant experience performing validation activities within pharmaceutical environment; or equivalent combination of education and experience.
--- Familiarity with current industry practices and guidelines including those required / outlined by the FDA, ISO, EU and ICH.
--- Proficiency in Microsoft Office including Word, Excel, PowerPoint, MS Project, Visio, etc.
Keywords: Renaissance LLC, Lakewood , Validation Engineer II, Engineering , Lakewood, New Jersey
here to apply!