This role is responsible for planning, executing and documenting commissioning, qualification and start-up activities for OEM process equipment and distributed control systems used within regulated pharmaceutical manufacturing environments. The position ensures automation and process systems are delivered, commissioned and transitioned to operations in full compliance with cGMP, safety and quality requirements.
Working closely with engineering, quality, validation, operations and external vendors, the role plays a key part in achieving safe, compliant and reliable plant start-up while supporting ongoing validation and continuous improvement initiatives.
Key Responsibilities
* Execute commissioning and start-up activities for projects involving OEM packaged equipment such as process skids, pumps, compressors, mixers, CIP/SIP systems, filling and packaging equipment within pharmaceutical facilities.
* Develop and deliver commissioning plans, pre-commissioning checklists, FAT and SAT protocols, IQ and OQ documentation, and support PQ execution where required.
* Perform control system testing including loop checks, logic verification, interlock and sequence testing, redundancy and failover testing, alarm verification, calibration checks and HMI validation.
* Inspect and verify field wiring, I/O installation, marshalling and cabinet power-up activities, ensuring all associated documentation such as drawings, I/O lists and cable schedules are accurate and controlled.
* Coordinate with calibration and metrology teams to confirm instrument calibration status and documentation prior to critical commissioning activities.
* Configure, tune and troubleshoot DCS and PLC-based control systems, including controllers, I/O, control strategies, operator interfaces, alarm management and historian connectivity.
* Participate in FATs and SATs for control systems and OEM equipment, documenting results, managing deviations and supporting CAPA activities.
* Diagnose and resolve instrumentation, automation and process issues during commissioning and early production, contributing to root cause analysis and corrective actions.
* Verify communications and data integrity between control systems and field devices, PLCs, SCADA, MES and other manufacturing systems, supporting data integrity and audit requirements.
* Commission batch, recipe and sequential control strategies, including PID tuning and advanced control functions to ensure consistent and repeatable operation.
* Collaborate with Quality and Validation teams to generate compliant, traceable documentation including URS, DQ, IQ/OQ, traceability matrices and computerized system validation records.
* Support alarm rationalisation, operator safety functions and emergency procedures in line with industry best practice.
* Coordinate with vendors, system integrators and site teams to resolve issues and achieve compliant system handover.
* Support electronic records, audit trails and data integrity requirements in line with regulatory expectations.
* Assist with operator training, preparation of SOPs and controlled work instructions.
* Participate in risk assessments, change control, design reviews and validation boards as required.
* Support post-start-up activities including performance optimisation, warranty support and lessons learned reviews.
* Ensure all activities comply with internal policies, regulatory requirements and current Good Manufacturing Practices.
Knowledge, Skills & Experience
* Degree in Automation, Control Systems, Electrical, Instrumentation, Mechanical Engineering or a related discipline, or equivalent experience.
* Minimum of 3 years' experience in commissioning, start-up or controls engineering within regulated manufacturing environments.
* Hands-on experience configuring and troubleshooting DCS, PLC and industrial automation systems.
* Strong understanding of field instrumentation, valves, motors, drives and rotating equipment commissioning.
* Solid knowledge of control strategies, PID tuning and automation architectures.
* Experience with industrial communication protocols such as HART, Modbus, PROFIBUS, Foundation Fieldbus and Ethernet-based networks.
* Ability to interpret P&IDs, loop diagrams, wiring schematics and I/O documentation.
* Strong organisational, communication and problem-solving skills with the ability to work across multi-disciplinary teams.
* Willingness to work on client sites and support extended hours during commissioning and start-up phases.