Spclst, Engineering

Job Description

An amazing opportunity has arisen for a Spclst, Engineering.

We are hiring an Instrumentation Engineer (SME) to oversee site-wide calibration and gas detection programs. In this role, you will manage CMMS and calibration data (ProCal or similar), maintain contract governance and oversight with our outsourced provider, support audits, and serve as the subject matter expert during regulatory inspections.

You will engage with and support local and global initiatives across EHS, Quality, Maintenance, and Engineering. You will uphold data integrity, ensure validated documentation standards, and contribute to reliability engineering efforts.

You build strong relationships across Production, Quality, EHS, and Engineering, delegate effectively within project teams, and balance people and business needs across programs and projects.

What you will do:

Bring energy, knowledge, innovation and leadership to carry out the following:

• System Owner of site calibration program for both instrumentation and gas detection systems.
• Be responsible for all aspects of the instrumentation and gas detection equipment installed on site eg: Lead RCA’s, quality deviations, Instrumentation performance reviews.
• Provide engineering support to both maintenance and equipment owners.
• Ensure maintenance program is appropriate for reliable operation of equipment.
• Support and/or lead instrument and equipment criticality assessments in line with GMP and risk-based approaches.
• Ensure calibration strategies align with criticality, risk, and validation status.
• Maintain criticality documentation and ensure alignment with site procedures.
• Maintain and optimise the CMMS and CCMS configurations (asset hierarchy, PM libraries, workflows) and ensure clean, reconciled reports.
• Master data accuracy (FLOCS/assets, BOMs, spare parts, vendor records, PMs) ensuring maintenance records are auditable and ALCOA+ compliant.
• Create and maintain work‑order & calibration impact matrices; develop CMMS workflows to prevent close‑out without required attachments and approvals.
• Maintain pre‑compiled audit packs/reports and ensure maintenance evidence (work histories, calibration certs, change controls, CAPAs) is readily retrievable, support inspections as the systems SME and address auditor queries regarding system controls and data integrity.
• Produce and maintain role based dashboards and reports covering maintenance performance workorder status, PM compliance.
• Participate in change control pertaining to all maintenance systems, and data quality. Manage process / equipment improvements through completion of projects as required.
• Act as a liaison between Maintenance, Quality/Validation and IT to ensure systems, processes and data meet operational, regulatory and financial requirements.
• Drive continuous improvement, identify need for new equipment and/or modifications to existing equipment to optimize throughput and reduce process cycle times.
• Troubleshoot equipment problems, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's.
• Drive and participate effectively in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various systems.
• Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor’s degree in manufacturing/mechanical/electrical/Instrumentation Engineering.
• Minimum 5 years in pharmaceutical manufacturing preferred.
• Solid understanding of GMP, validation, data integrity, and regulatory expectations for calibration and maintenance.
• Proficient with CMMS/CCMS management tools and technical documentation in a validated environment.
• Lean Six Sigma methodology experience.
• Demonstrated troubleshooting skills and cross-functional collaboration.
• The desire to continuously learn, improve and develop.
• Willingness to support the team and a strong focus on delivering excellence.
• Demonstrating energy and enthusiasm, the engineer, will be a role model for operational excellence, and will contribute to the organisation’s overall capability to thrive and grow.
• Proven track-record in delivering resu