Role Description:
Responsible for planning, executing and documenting commissioning, qualification and start-up activities for OEM equipment and Emerson DeltaV control systems used in pharmaceutical manufacturing facilities. Ensures systems are delivered, commissioned and handed over to operations meeting regulatory, quality and safety requirements (cGMP, FDA, EMA). Works closely with engineering, QA/sterility, validation, operations and vendors to achieve compliant, safe and reliable plant start-up.
This role supports validation, regulatory compliance, and continuous improvement initiatives critical to Good Manufacturing Practices (GMP).
Role Functions:
Commissioning and start-up activities for projects involving OEM packaged systems (skids, pumps, compressors, mixers, CIP/SIP skids, filling and packaging equipment) and Emerson DeltaV DCS in pharmaceutical facilities.
Develop and execute commissioning plans, pre-commissioning checklists, FAT/SAT procedures, Installation Qualification (IQ), Operational Qualification (OQ) and support Performance Qualification (PQ) activities as required.
Perform loop checks, logic verification, interlock and interlock sequence testing, failover and redundancy tests, alarm verification, calibration verification and HMI validation.
Inspect and verify I/O wiring, marshalling, cabinet terminations and cabinet power-ups; ensure documentation (as-built drawings, cable schedules, I/O lists) is maintained and controlled.
Ensure instrument calibration status, calibration labels, and calibration records are in place before critical commissioning activities; coordinate with Metrology/Calibration teams.
Configure, tune and troubleshoot DeltaV controllers, I/O, control modules, operator displays, alarm management and historian interfaces to meet process and regulatory requirements.
Participate in the execution of FATs and SATs for DeltaV systems and associated OEM equipment; prepare and review test protocols and detailed test records. Document results, manage deviations and non-conformances, and support CAPA activities.
Troubleshoot instrumentation, control system faults and process issues during commissioning and early production; propose corrective and preventive actions and support root cause analysis.
Ensure communications and data integrity between DeltaV and field devices (HART, Foundation Field bus, Modbus), PLCs, MES, SCADA and LIMS. Validate data flows and timestamps to support data integrity requirements.
Commission and validate control strategies, PID tuning, recipe/batch control modules, sequential function charts and advanced control modules, ensuring deterministic behaviour across batch runs.
Collaborate with Quality/Validation teams to produce traceable, auditable commissioning and qualification documentation (protocols, URS, DQ, IQ/OQ, traceability matrices, CSV artefacts).
Verify proper implementation of alarm rationalisation, alarm shelving policies and operator interventions consistent with pharmaceutical safety and quality practices.
Coordinate with OEM vendors, system integrators, QA/Validation, utilities and operations to resolve issues and ensure compliant handover.
Support data integrity, electronic records and signatures (ERES), audit trails, and 21 CFR Part 11 expectations for computerised systems.
Provide guidance for operators and maintenance personnel on control strategies, alarms, emergency procedures and batch operations; prepare operating procedures and controlled work instructions.
Participate in risk assessments (e.g., FMEA), change control, design reviews and validation review boards as needed.
Support post-commissioning activities including performance optimization, handover packages, warranty claims and lessons learned sessions.
Ensure Automation compliance 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.
Requirements
Must Have:* Bachelor’s degree in Control Systems Engineering, Electrical Engineering, Instrumentation, Mechanical Engineering or related field (or equivalent experience).
3+ years’ experience in commissioning, start-up or controls engineering with exposure to OEM equipment and DCS projects; DeltaV-specific experience preferred.
Proven hands-on experience configuring and troubleshooting Emerson DeltaV systems (system configuration, control modules, graphics, Alarm and Event, historian).
Familiar with field instrumentation, valves, motors, drives, and rotating equipment commissioning and testing.
Solid knowledge of PID control, control loops, control strategies and tuning techniques.
Experience with communication protocols: HART, Modbus, Foundation Field bus, PROFIBUS, Ethernet/IP.
Ability to read P\&IDs, loop diagrams, wiring diagrams and I/O lists.
Strong problem-solving, organizational and communication skills; able to coordinate multi-discipline teams on-site.
Willingness to travel and work at client sites; able to work extended hours during commissioning and start-up phases.
Valid driver’s license and ability to pass site background and safety checks.
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Preferred qualifications:
Hands-on DeltaV certification(s) or Emerson-authorized training.
Experience with PLCs (Allen-Bradley/Rockwell, Siemens), SCADA systems and MES integration.
Knowledge of process industries: oil \& gas, petrochemical, chemical, power, water/wastewater, pharmaceuticals or food \& beverage.
Experience with safety instrumented systems (SIS), SIL assessments, and emergency shutdown systems (ESD).
Familiarity with FAT/SAT procedures and quality systems (ISO, API standards).
Experience with commissioning management software and project HSEQ (health, safety, environment \& quality) systems.