Validation Engineer II

Overview:

The Validation Engineer II 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.

Responsibilities:

• 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
• Manage seasonal temperature mapping studies of warehouse areas and CTU for the site.
• Generate final reports, compile historical data packages, and route documents for approval.
• Review and approve set-up and operation procedures for production and packaging equipment.
• Generate risk assessments to discuss the approach to qualification related activities.
• Support the rationale for the sample size selection during process equipment qualification.
• Review and complete assigned Change Control tasks.

Qualifications:

• 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.