Walker Cole International is supporting a leading pharmaceutical manufacturer in the appointment of an Automation Engineer to support a major ongoing automation and software validation project within a GMP-regulated manufacturing environment.
This position will focus heavily on DeltaV software validation activities, supporting system execution, commissioning, troubleshooting and compliance activities across a complex pharmaceutical site. The successful candidate will play a key role in ensuring systems are validated and operational in line with regulatory and project requirements.
Key responsibilities:
- Generate and execute CSV and commissioning lifecycle documentation including Risk Assessments, URS, DQ, RTM, IOQ Protocols and IOQ Reports for DeltaV-controlled systems.
- Support validation and execution activities across Emerson DeltaV automation and Process Control Systems (PCS).
- Perform P&ID walkdowns and system verification activities to ensure alignment between design documentation and installed systems.
- Review and approve vendor FAT/SAT documentation relating to DeltaV automation systems and integrated process equipment.
- Support SAT execution activities, including vendor coordination, witnessing and client-side sign-off of SAT documentation.
- Troubleshoot automation and control system issues during commissioning, start-up, energisation and shakedown activities.
- Support integration and validation activities across process equipment, utilities and manufacturing systems connected to DeltaV.
- Raise, manage and support closure of deviations, change controls and commissioning issues throughout project execution.
- Work closely with Automation, Engineering, CQV and Manufacturing teams to ensure successful project delivery and GMP compliance.
Required experience and skills:
- Proven experience delivering CSV, CQV or automation validation activities within GMP-regulated pharmaceutical environments.
- Strong hands-on experience with DeltaV systems within pharmaceutical or biotech manufacturing.
- Strong automation and controls background, including troubleshooting during live commissioning and field execution activities.
- Experience supporting FAT, SAT, IOQ and integrated system testing activities.
- Familiarity with GMP regulations, GAMP 5, 21 CFR Part 11, EU Annex 11 and Data Integrity requirements.
- Understanding of PCS-integrated systems and automated manufacturing environments.
- Ideally experience with DeltaV configuration, programming or coding support.
- Strong stakeholder management and communication skills within cross-functional project teams.
Working pattern:
Fully onsite
Employment type:
Contract
Location:
North East, England, United Kingdom
Keywords:
Automation Engineer | DeltaV | Automation | Emerson | Emerson DeltaV | GMP | GAMP 5 | 21 CFR Part 11 | Annex 11 | Data Integrity | Pharmaceutical | Commissioning | Qualification | FAT | SAT | PCS | IOQ
ID: 105655