Senior Facilities Engineer - Biotech cGMP Ops

WaveCrest Staffing Group; South San Francisco (CA); Vor Ort; USD 130.000 - 190.000; Vollzeit

Zusammenfassung

WaveCrest Staffing Group is assisting a Bay Area client in finding an experienced Senior Engineer to support facility operations, utilities, and equipment across two locations in the Bay Area within a cGMP-regulated environment.

You will own assigned utilities and equipment, supervise HVAC, temperature-controlled systems, autoclaves, process gases, and water systems; lead projects from planning through execution and ensure compliance through QA, deviations, CAPAs, and change controls.

Qualifikationen

• Bachelor’s degree in Engineering or equivalent.
• 8+ years of relevant industry experience in plant engineering or operations.
• Working knowledge of cGMP requirements and equipment qualification.

Aufgaben

• Provide technical support for facility equipment and utilities, including HVAC, temperature-controlled units, autoclaves, process gases, and water systems.
• Serve as system owner for assigned utilities and equipment, ensuring reliable performance and regulatory compliance.
• Lead troubleshooting, lifecycle management, and engineering improvements.
• Develop and maintain technical documentation, including SOPs, commissioning/qualification documents, drawings, and change controls.
• Support cGMP compliance activities, including deviations, CAPAs, calibration, maintenance, and qualification.
• Lead engineering projects from planning and budgeting through execution, ensuring timelines and requirements are met.
• Provide technical guidance to operations teams and contractors to optimize facility systems.

Kenntnisse

Project management

Communication

Problem solving

Organizational skills

Ausbildung

Bachelor’s degree in Engineering or equivalent

8+ years of relevant industry experience in plant engineering/operations

Tools

cGMP knowledge

Instrumentation

Calibration

Change control

Equipment qualification

Jobbeschreibung

WaveCrest Staffing Group is assisting a Bay Area client in finding an experienced Senior Engineer to support facility operations, utilities, and equipment across two locations in the Bay Area within a cGMP-regulated environment.

You will own assigned utilities and equipment, supervise HVAC, temperature-controlled systems, autoclaves, process gases, and water systems; lead projects from planning through execution and ensure compliance through QA, deviations, CAPAs, and change controls.