Position Details

•    Manage the maintenance team.
•    Plan schedule to various planning horizons, ensuring that vendor lead maintenance is booked & the appropriate EHS & PO is in place.
•    Work with Scheduler to plan access to equipment, facilities & utilities.
•    Work with QC to plan appropriate timeslots access to Lab equipment, facilities & utilities.
•    Implement team workload planner to track & ensure visibility to maintenance schedule, balancing workload.
•    Ensure that all equipment, utilities & facilities are maintained.
•    Prioritise workload for team aswell as contingent workers to maintain equipment in validated state to support production. 
•    Manage Work Orders, ensuring timely approval & closure of Work Orders to confirm correct work completed, correct documentation & accurate metrics.
•    Assign each eMaint asset a primary & secondary maintenance engineer.
•    Develop & implement preventive & predictive programs for all GMP critical assets.
•    Ensure all maintenance activities are in compliance with EU GMP, EHS, & other regulatory standards.
•    Manage service contracts & vendor performance for critical systems & calibration services.
•    Ensure SLA’s in place with vendors.
•    Manage the team on-call rota & provide on call cover for the site one week per month or as per business requirements.
•    Responsible for ensuring maintenance related deviations, CAPA’s & change controls are completed on time & to the required standard.
•    Support regulatory inspection & internal audits; lead investigations & CAPA implementation. 
•    Coordinate with Manufacturing, Quality, Validation, & Engineering teams to ensure operational continuity & improvement. 
•    Prepare & manage budgets & KPIs. 
•    Lead root cause analysis & continuous improvement projects to optimise equipment reliability & uptime. 
•    Manage training on SOP’s, work instructions & OJT to ensure compliance and no overdue training. 
•    Support the introduction of new equipment or technology. 
•    Perform duties in a compliant manner & accordance with site SOPs, EHS standards & guidelines, & relevant legal requirements.
•    Other duties. Job Specific Technical, Functional and Professional Competencies:
•    In-depth knowledge of EU GMP regulations, especially Annex 1 & Annex 15. 
•    Proven experience with CMMS.
•    Familiarity with utilities & cleanroom environments. 
•    Must have a strong technical aptitude.
Essential Education and Experience:
•    Bachelor’s Degree in Engineering (Mechanical, Electrical, or related field).
•    Minimum of 5years’ experience in maintenance management, including people management, in a GMP-regulated pharmaceutical or biotech environment.Desired Education and Experience:
•    Experience with automation & building management systems.
•    Experience supporting sterile/aseptic manufacturing or vaccine production is a strong advantage.
•    Six Sigma, Lean or Reliability Certifications. Project management experience in capital or upgrade projects.