Engineering Coordinator in Llandysul

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 escalate, defer, or halt engineering activities where cGMP, Safety, or Compliance risks are identified, in line with site escalation and governance procedures.

Responsibilities:

• Engineering, Maintenance & Calibration Coordination: 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.
• CMMS & Asset Management: 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.
• GMP Compliance & Regulatory Support: 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.
• Contractor & Vendor Management: 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.
• Cross-Functional Coordination: 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.
• Documentation & Reporting: 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; Maintain and control engineering stores operations, ensure stock and levels remain up to date; Re-order stock as and when necessary and ensure the completion of stock checks during the financial year; Use KPI and trend data to identify opportunities for reliability improvement and continuous improvement initiatives.

The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

To be successful in this role:

• Experience: Experience in pharmaceutical, biotechnology, or other regulated manufacturing environments; Proven experience in maintenance coordination, asset management, or engineering operations; Familiarity with cleanroom environments and critical utilities (HVAC, WFI, clean steam, compressed gases).
• Technical Knowledge: GMP and regulatory expectations (e.g., MHRA, FDA); Maintenance strategies (PPM, predictive maintenance); Equipment qualification and validation principles; CMMS/EAM systems.
• Skills & Competencies: Strong organisational and planning skills; Effective cross-functional communication and stakeholder management; Problem-solving and analytical thinking (RCA, FMEA); Attention to detail and documentation accuracy; Ability to work in a fast-paced, regulated environment; Leadership and coordination capability (formal or informal); Ability to challenge, escalate, and influence to maintain GMP standards.
• Behavioural Competencies: Quality and compliance mindset (“right first time”); Proactive and solution-oriented approach; High integrity and accountability; Resilience under operational pressure.