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.