Engineering Maintenance Project Lead

Come and Save Lives with Us! SERB is a fast-growing specialty pharmaceutical company that equips healthcare providers worldwide with life-saving medicines for patients facing rare conditions and emergencies. For over 30 years we have consistently provided emergency medicines, medical countermeasures, and the world’s leading portfolio of antidotes. Today SERB has over 500 employees in 18 countries and group revenue in excess of €400m. With a strong presence in the US, Europe, and the Middle East, along with a global network of trusted distribution partners, we make a broad range of essential medicines available in over 100 countries. Having the right culture is as important to us as having the right portfolio. We are guided by our four values:

• We make patients our priority
• We act with accountability and integrity
• We work together as one team
• We look for better ways forward

By expanding our reach through selective acquisitions and entering new markets, we’re not just supplying medicine; we’re improving the standard of care for more patients around the world.

Broad Overview: This position will be responsible for configuring, delivering and validating efficient and effective maintenance and calibration processes at SERB in alignment with best practices in cGMP pharmaceuticals.

As Engineering Maintenance Project Lead, your responsibilities will include:

• Implementing, validating, and embedding robust engineering maintenance and calibration processes and systems aligned with cGMP and industry best practices.
• Leading the end‑to‑end transformation of maintenance and calibration data, processes, and governance, including:

• Cleansing and standardising engineering master data
• Implementing a new Computerised Maintenance & Calibration Management System (CMMS)
• Designing and deploying associated procedures, KPIs, and reporting
• Ensuring full computer system validation (CSV) and sustainable business adoption

Key Accountabilities:

1. Engineering Maintenance & Calibration Data Transformation
   • Lead the review, cleansing, enrichment, and standardisation of maintenance and calibration master data, including (but not limited to):
   • Equipment and Instrument Master Data
   • Functional Location hierarchies
   • Task Lists, Maintenance Plans, and Calibration Strategies
   • Bills of Material and Spare Parts
2. Define and implement data governance principles, ownership, and quality rules to ensure data integrity is maintained post‑project
3. Prepare, validate, and execute data migration from legacy systems and spreadsheets into the target CMMS
4. Develop reconciliation and reporting mechanisms to assure data completeness and accuracy
5. CMMS & Calibration System Implementation
   • Support the selection and implementation of a CMMS suitable for managing maintenance and calibration across SERB
   • Lead system configuration to align with defined best‑practice maintenance and calibration workflows
   • Own and deliver computer system validation activities, specifically critical User Acceptance Testing (UAT)
   • Define and validate calibration workflows, certificates, tolerances, scheduling, escalation rules, and compliance controls
   • Act as business Subject Matter Expert, working closely with IT, system integrators, and vendors
6. Process Design, SOPs & Governance
   • Design and document end‑to‑end “To‑Be” maintenance and calibration processes, ensuring alignment with GMP expectations
   • Author or update SOPs, Work Instructions, and system user guides supporting:
   • Maintenance planning and scheduling
   • Calibration execution and compliance
   • Data governance and master data lifecycle
7. Implement change control and validation documentation in accordance with SERB Quality Systems
8. Establish governance forums (e.g. process boards or review meetings) to support decision‑making and sustainability
9. KPIs, Reporting & Performance Management
   • Define and implement maintenance and calibration KPIs, including (examples):
   • Schedule adherence, Calibration compliance, Preventive vs corrective maintenance ratios
   • Backlog health and work order quality, Data quality indicators
10. Use KPI insight to drive continuous improvement opportunities and corrective actions
11. Training, Change & Adoption
    • Develop and deliver training materials and sessions for engineers, planners, technicians, and key users
    • Lead User Acceptance Testing (UAT) and business readiness activities
    • Drive change management, ensuring new processes and systems are understood, adopted, and embedded
    • Provide post‑go‑live stabilisation support and handover to BAU teams
12. Project & Stakeholder Management
    • Manage scope, timelines, risks, and dependencies across the maintenance and calibration workstream
    • Coordinate internal and external resources, including contractors, system integrators, and vendors
    • Provide regular progress updates, status reports, and risk escalations to stakeholders
    • Ensure alignment with SERB policies, Quality Systems, and global standards

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, you should demonstrate:

Essential:

• Significant experience in engineering maintenance and calibration within GMP pharmaceutical or regulated manufacturing environments
• Proven delivery of maintenance data cleansing, standardisation, and migration
• Hands‑on experience with CMMS implementation and computer system validation (IQ/OQ/PQ/UAT)
• Strong understanding of maintenance planning, calibration compliance, and data governance
• Ability to translate business needs into clear processes, data models, and system requirements
• Excellent stakeholder management and communication skills

Desirable:

• Experience with SAP PM / S/4HANA, IBM MAXIMO or similar enterprise maintenance systems
• Experience in implementing or managing calibration systems (e.g. cloud‑based CMS)
• Knowledge of GAMP, GMP Annex 11, and data integrity principles
• Background in process transformation or continuous improvement
• Experience defining and implementing maintenance KPIs and dashboards

Personal Attributes:

• Structured, detail‑oriented, and data‑driven
• Able to work autonomously while influencing across functions
• Pragmatic problem solver with a continuous improvement mindset
• Comfortable operating in a fast‑paced, regulated project environment

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.