Sr. Princ. Process Engineer - DP Aseptic Biotherapeutic Filling Equipment

Senior Principal Process Engineer for aseptic biotherapeutic filling equipment at Johnson & Johnson's Wilson, North Carolina facility. Lead end-to-end process engineering for design, implementation, and start-up of state-of-the-art aseptic filling line systems in a new cGMP manufacturing facility.

Responsibilities

• Lead development of aseptic filling line documentation including URS, specifications, P&IDs, and process flow diagrams
• Evaluate and select equipment vendors through technical assessment, bid review, and vendor discussions
• Design and engineer aseptic filling line equipment in collaboration with suppliers and stakeholders
• Own filling line layout, design, and facility integration ensuring Annex 1 compliance
• Serve as technical lead for FAT, SAT, C&Q, and start-up of aseptic filling systems

Requirements

• Bachelor's degree in engineering (Mechanical preferred); MS or MBA preferred
• Minimum 10 years process engineering experience with aseptic filling systems for biotherapeutics
• Demonstrated technical leadership on sterile injectable biologics filling operations
• Hands-on experience designing, commissioning, and qualifying aseptic filling line systems
• Deep knowledge of FDA cGMP and EU Annex 1 aseptic manufacturing regulations
• Proven ability to lead cross-functional teams in matrixed environments
• Extensive experience managing external partners including A&E firms and equipment vendors