Engineering Manager
On-siteStevenage, England, United Kingdom
Job Summary
Lead a multiskilled engineering team in maintaining specialist pharmaceutical equipment and facility installations to support manufacturing and QC operations. Diagnose faults, repair equipment breakdowns, and execute reactive and planned maintenance works within GMP facilities while conducting risk assessments. Manage critical spares, oversee contractors, and create maintenance procedures including SOPs to ensure equipment is returned to production in 100% safe condition. Verify GDP, ALCOA, GMP, and GEP practices in the CMMS and represent Engineering at multi-departmental meetings. Schedule is shift-based (2-on/2-off, 3-on/2-off, 2-on/3-off) rotating between early (6:00 AM–4:00 PM) and late (11:00 AM–11:00 PM) shifts every 14 days.
Required Qualifications
- Bachelor of Science – Relevant engineering degree or HNC/D with relevant experience
- 3 years of working within a clean room or regulated environment
- Operating within the requirements of a Quality Management system
- Control system (PLC) experience
- CMMS experience
- Experience of managing and performing planned preventive maintenance
- Experience in GMP standard quality management systems (i.e. CAPAs, CCs & Deviations)
- Knowledge and expertise in utility systems from HVAC to medical gasses etc
Desired Qualifications
- Working in a Pharmaceutical or other heavily regulated industry
- Project management experience
- Equipment validation lifecycle knowledge
- Knowledge of current standards, procedures, and controls for GMP cleanroom facilities and equipment
- Knowledge and expertise in small scale pharmaceutical manufacturing equipment
- Knowledge of pharmaceutical utility systems and controls
- BMS and EMS
- Clean room operations
- Computer literate - Microsoft Office suite
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