Job Description

Renaissance LLC

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.

Overview

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.

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.

• 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.

Renaissance Lakewood