Engineer – Biologics Drug Substance PPQ support (JP14922)

3 Key Consulting • Holly Springs, NC

34d • Hybrid

About The Position

3 Key Consulting is hiring an Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company. Ideal Candidate: B.S and 1-3 YOE, M.S. with some experience is ideal. Nice to have: Chemical engineering or bioprocessing experience. Process validation or development experience. Technical platforms: Spotfire, Excel, Smartsheet. Job Details: Position involves support of senior staff in the initiation, design, and delivery of projects, particularly for process validation scope. Employ basic engineering/validation skills and practices to gather process validation acceptance criteria, process parameter data, and performance indicator data to support PPQ campaigns. Assist with process validation documentation by documentation reviews and data verification of protocols and reports. Perform process validation floor support as needed for sample management verification. Assist in developing sample packages to support MFG, validation datasheets, raw material inventory for studies, and supporting supply chain needs for validation activities

Requirements

• Experience with excel, data verifying, and documentation experience.
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
• Worked in a process validation team or process development team for drug substance biologics

Nice To Haves

• Chemical engineering or bioprocessing experience.
• Process validation or development experience.
• Technical platforms: Spotfire, Excel, Smartsheet.

Responsibilities

• Support process validation team in the initiation, design, and delivery of projects, particularly for process validation scope.
• Assist with gathering process validation data, data verifying protocols/reports, and double-checking sample collection

What This Job Offers

• Career Level: Entry Level