Note: This role is not set up for Visa sponsorship, visa transfer after OPT, or third-party C2C.
Candidate 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 the generation of qualification/validation documents, execution of qualification/validation documents, generation of reports, managing project timelines, and participating in cross-functional teams.
Responsible for the validation studies required for qualifying Manufacturing, Packaging equipment and Pharmaceutical utilities, including HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen.
Collect and tabulate laboratory data, review laboratory data for errors and discrepancies, and transcribe results into final reports.
Generate, review, and approve qualification/validation procedures.
Provide mentorship to less experienced validation engineers in the team and handle projects assigned to validation contractors
Qualifications:
Bachelor's Degree in Engineering, Life Sciences, or related discipline, with a minimum of 3 years of relevant experience performing validation activities within the pharmaceutical environment; or an equivalent combination of education and experience.
Familiarity with current industry practices and guidelines including those required/outlined by the FDA, ISO, EU and ICH.