Engineering Maintenance Project Lead

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.

The role acts as the bridge between Engineering, Quality, Production and Digital/IT, ensuring solutions are practical, compliant, and deliver measurable business value.

Lead the review, cleansing, enrichment, and standardisation of maintenance and calibration master data, including:

• Equipment and Instrument Master Data
• Functional Location hierarchies
• Task Lists, Maintenance Plans, and Calibration Strategies
• Bills of Material and Spare Parts

Define and implement data governance principles, ownership, and quality rules to ensure data integrity is maintained post‑project.

Prepare, validate, and execute data migration from legacy systems and spreadsheets into the target CMMS.

Develop reconciliation and reporting mechanisms to assure data completeness and accuracy.

• 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.

• 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, scheduling, calibration execution, data governance, change control, validation documentation, and governance forums.

• Define and implement maintenance and calibration KPIs, including schedule adherence, calibration compliance, preventive vs. corrective maintenance ratios, backlog health, work order quality, and data quality indicators.
• Use KPI insights to drive continuous improvement opportunities and corrective actions.

• 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.

• 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.

• 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…