Engineering Coordinator

Broad Overview:

The Engineering Coordinator is responsible for planning, coordinating, and monitoring engineering, maintenance and calibration activities within a pharmaceutical manufacturing environment. This role ensures that all engineering, maintenance and calibration operations support safe, compliant, and efficient site operations in alignment with current Good Manufacturing Practice (cGMP).

The Engineering Coordinator operates as an integral part of the Quality Management System (QMS), acting as a key interface between Engineering, Production, Quality, EHS and External Contractors, ensuring that equipment, utilities, and facilities remain in a validated, controlled, and inspection‑ready state throughout their lifecycle.

The role has the authority to elevate, defer, or halt engineering activities where cGMP, Safety, or Compliance risks are identified, in line with site escalation and governance procedures.

• Coordinate planned preventative maintenance (PPM) and reactive maintenance (UPM) activities
• Prioritise engineering tasks in line with production schedules, asset criticality, and GMP impact
• Allocate engineering resources and manage daily work plans
• Ensure maintenance and calibration activities are planned, risk‑assessed, documented, reviewed, and executed in accordance with cGMP and GEP requirements
• Coordinate maintenance shutdowns and minimise production disruption
• Ensure maintenance and calibration activities do not compromise validated state or environmental control

• Administer and maintain CMMS (e.g., SAP, Maximo) as the system of record, in compliance with cGMP and data integrity requirements
• Maintain asset registers and oversee lifecycle management of equipment (installation, qualification, maintenance, retirement)
• Review and approve maintenance documentation for completeness and compliance
• Utilise CMMS/EAM systems (e.g., SAP, Maximo) for work order management
• Support periodic system reviews, data integrity assessments, and validation activities
• Maintain asset criticality classifications and risk assessments, ensuring maintenance strategies remain appropriate
• Ensure ALCOA+ data integrity principles are applied to all engineering and maintenance records

• Ensure all engineering, maintenance and calibration activities comply with GMP, GEP, and health & safety regulations
• Maintain engineering documentation (SOPs, logbooks, maintenance records) in audit‑ready condition at all times
• Support internal audits, regulatory inspections
• Create and participate in deviation investigations, root cause analysis, CAPA, and change control processes
• Author, complete and contribute to engineering change controls and provide technical impact assessments

• Schedule suppliers of services and products for manufacturing and utilities equipment in line with contractual agreements. Maintain and develop effective relationships with external contractors such that support is available when required, that the work is of a suitable standard and at a fair price
• Coordinate and supervise third‑party contractors and service providers on site
• Ensure contractor compliance with site procedures, permits, and GMP requirements
• Review and approve contractor documentation and service reports
• Ensure site ownership of all contractor‑performed GMP‑impacting activities
• Manage external contractor service contracts

• Act as the primary engineering contact for manufacturing operations
• Liaise with Quality Assurance, Validation, Production, and Supply Chain teams
• Ensure effective communication of maintenance plans, risks, and constraints to production, QA and EHS

• Generate and maintain engineering KPIs (e.g., uptime, backlog, compliance metrics)
• Prepare reports, risk assessments, and technical documentation
• Ensure timely closure of work orders and deviations
• To maintain and control engineering stores operations, ensure stock and levels remain up to date. Re‑order stock as and when necessary and ensure the…