Senior GxP Facilities Engineer Onsite, Impactful Compliance

Vertex Pharmaceuticals Inc (US); Leiden; Vor Ort; EUR 90.000 - 136.000; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals Inc. (US) is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for facility, process, instrumentation, and regulatory needs at Vertex GxP facilities.

You will collaborate with Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams and site leadership to meet facility and manufacturing needs. The role involves various equipment and infrastructure-focused engineering efforts, design reviews, lifecycle

Qualifikationen

• Knowledge of cGMP and regulated facility design, change control, commissioning, qualification, validation.
• Experience with capital projects and process/facility equipment.
• Strong communication and teamwork across cross-functional groups.

Aufgaben

• Collaborate with scientific groups to understand evolving science and technology.
• Execute change management for facilities and related systems including commissioning.
• Lead design reviews for capital projects to optimize cost, efficiency and compliance.
• Prepare and review system lifecycle documents (P&IDs, I&C diagrams, user specs, CQV, SOPs).

Kenntnisse

GxP knowledge

Facility design

Regulatory compliance

Capital projects

Change management

Ausbildung

Bachelor's degree in Chemical/Mechanical/Electrical Engineering

Jobbeschreibung

Vertex Pharmaceuticals Inc. (US) is seeking a GxP Site Engineering Senior Specialist to represent Global Engineering for facility, process, instrumentation, and regulatory needs at Vertex GxP facilities.

You will collaborate with Facilities Operations, Advanced Manufacturing Engineering, Project Engineering, PMO, CMC teams and site leadership to meet facility and manufacturing needs. The role involves various equipment and infrastructure-focused engineering efforts, design reviews, lifecycle