Sterile Process Equipment Engineer - Greenfield Facility

Serovia; Branchburg Township (NJ); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Serovia’s Branchburg, NJ facility seeks a Process Equipment Engineer to lead design, qualification, and ongoing reliability of sterile injectable manufacturing equipment. You will collaborate across Validation, Quality, and Operations to ensure cGMP compliance and readiness from day one of operations.

Responsibilities include vendor management, FAT/SAT, IQ/OQ/PQ support, and development of maintenance programs to sustain equipment performance and safety in a fast-paced startup-like environment.

Qualifikationen

• Bachelor’s degree in mechanical, chemical, industrial engineering or related field.
• 3+ years of pharmaceutical process equipment engineering, sterile injectable manufacturing preferred.
• Experience with aseptic manufacturing equipment design, qualification, and cleanroom environments.
• Strong knowledge of cGMP, FDA/EMA expectations, and safety standards.

Aufgaben

• Lead specification, selection, and procurement of sterile injectable process equipment.
• Develop URS, FS, and equipment design documentation.
• Manage vendors, FAT/SAT, installation, and commissioning.
• Support IQ/OQ/PQ and regulatory readiness.
• Establish preventive maintenance and lifecycle plans.
• Collaborate with Validation, Quality, and Operations teams.

Kenntnisse

Process equipment engineering

Project management

GMP compliance

Problem solving

Cross-functional collaboration

Ausbildung

Bachelors in mechanical/chemical/industrial engineering

Jobbeschreibung

Serovia’s Branchburg, NJ facility seeks a Process Equipment Engineer to lead design, qualification, and ongoing reliability of sterile injectable manufacturing equipment. You will collaborate across Validation, Quality, and Operations to ensure cGMP compliance and readiness from day one of operations.

Responsibilities include vendor management, FAT/SAT, IQ/OQ/PQ support, and development of maintenance programs to sustain equipment performance and safety in a fast-paced startup-like environment.