Validation Engineer
Validation Engineer
6-month contract role - ONSITE
Location: Germantown, WI
Job Role Summary:
This role will report to the Director, Engineering & Validation and support periodic validation (PVR) reviews for a pharmaceutical API manufacturing facility. The selected individuals will work independently on the PVR assessments and/or remediation plans. This shall include protocol development, executing and final report preparation.
The following is a list of typical in-scope systems (but not limited to):
· Freezers, Coolers, Tray Dryers
· Reactors
· Ovens
· Stability Chambers
· Filter Dryers
· Filter Presses
· Centrifuges
· Rotovaps
· RODI Water Systems
· Compressed Air Systems
· N2 Systems
Job Role Responsibilities:
· For each system, the selected candidate will be required to author PVR validation protocols, assess calibration/maintenance status, preform temperature mapping for coolers, freezers, & tray dryers, field verify drawings, complete all equipment operational tests, obtain post-approval for validation packages, follow up on any open items, and author a final report.
· Communicate project status effectively at all levels within the organization.
· Comply with site wide procedures including change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
· Can-do attitude and work ethic to take full ownership and proactive measures in managing capital projects.
Education, Experience, Skill Qualifications:
· A Bachelor’s of science degree in Pharmacy, Engineering or Science is required.
· 3+ years of experience in life sciences engineering is required.
· 1+ years of experience in validation is required.
· Experience working in FDA/cGMP compliant environment required.
· Strong collaboration, communication, and presentation skills required.
· Proficiency in Excel / Word / Outlook.
· Strong analytical and problem-solving skills.
· Good people management, direct or indirect management, skills.
· Good communication skills, proactive, good initiative and ability to work under pressure.