Title : Validation Engineer II (Pharma)
Job Status : Full-time direct hire
Location : Lakewood, New Jersey
Onsite expectation : 5 days a week
Compensation : $89,000 to $92,000 DOE
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.
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