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Engineering Coordinator
SERB PharmaceuticalsEngineering Coordinator responsible for coordinating engineering, maintenance, and calibration activities at SERB Pharmaceuticals. Ensuring cGMP compliance and efficient site operations within regulated pharmaceutical environment.
About the role
Key responsibilities & impact- 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 minimize 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
- Act as the primary engineering contact for manufacturing operations
- Liaise with Quality Assurance, Validation, Production, and Supply Chain teams
- Generate and maintain engineering KPIs (e.g., uptime, backlog, compliance metrics)
Requirements
What you’ll need- 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)
- GMP and regulatory expectations (e.g., MHRA, FDA)
- Maintenance strategies (PPM, predictive maintenance)
- Equipment qualification and validation principles
- CMMS/EAM systems
- 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
Benefits
Comp & perks- Competitive compensation & benefit packages
- Challenging opportunities
- Supportive work culture based on strong values
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
planned preventative maintenancereactive maintenanceasset managementmaintenance coordinationequipment qualificationvalidation principlesrisk assessmentsdata integrityroot cause analysisengineering change controls
Soft Skills
organisational skillsplanning skillscross-functional communicationstakeholder managementproblem-solvinganalytical thinkingattention to detailleadership capabilitycoordination capabilityinfluencing skills