Senior Facilities Engineer GMP Manufacturing

About the role

The Facilities and Engineering Support Specialist supports the integrity and compliance of F&E and CLIENT manufacturing facilities. The role supports quality systems, documentation changes, OEFM electronic forms, and the pest control program.

Responsibilities

• Provide primary support for deviations, Corrective and Preventive Actions (CAPAs), Change Controls, and related quality documentation.
• Investigate and document deviations from established procedures or specifications according to applicable Standard Operating Procedures (SOPs).
• Work with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
• Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
• Facilitate and manage documentation changes related to facilities and engineering processes, following regulatory guidelines, internal quality standards, and industry best practices.
• Collaborate with stakeholders to implement documentation changes efficiently.
• Support the creation, completion, review, routing, and tracking of OEFM electronic forms. Ensure forms are accurate, maintained according to applicable procedures, and processed within required timelines.
• Work with F&E, Quality, and other cross-functional teams to resolve OEFM form-related questions or issues.
• Support the transformation of the Pest Control program into a state of the art program.
• Collaborate with external pest control vendors and internal teams to address and resolve pest control issues, and support related documentation and records.

Datos clave

• The role supports F&E and CLIENT manufacturing facilities.
• Responsibilities include quality systems, documentation changes, OEFM electronic forms, and pest control program support.