Project Engineer - Automation

Project Engineer – Automation
£50k - £70k + package
Pharma, life sciences, BMS / SCADA
 
Our client is a market leading engineering consultancy who are seeking an experienced Automation Engineer to support the delivery of a major sterile manufacturing and facility expansion programme within a highly regulated GMP environment.
 
The role will provide technical leadership and oversight for automation systems associated with process equipment, cleanroom facilities and critical utilities. Working as part of an integrated project team, you will support the development, implementation, testing and qualification of automation solutions while ensuring compliance with quality, regulatory and digital standards.
 
This is an excellent opportunity for an automation professional with experience in pharmaceutical, biotechnology, advanced manufacturing or other regulated industries.
 
You’ll be responsible for:

Developing and implementing automation strategies aligned with project and client digital standards.
Producing and review user requirement specifications (URS), functional design specifications (FDS) and system design specifications (SDS).
Providing technical oversight of PLC, SCADA, DCS and building management system (BMS) solutions.
Managing integration of automation systems with site infrastructure, manufacturing execution systems (MES), historians and other digital platforms.
Supporting data integrity, computer system validation (CSV) and cybersecurity requirements for regulated systems.
Reviewing vendor and contractor automation designs, specifications and technical submissions.
Participating in design reviews, risk assessments, FMEA workshops and qualification activities.
Supporting factory acceptance testing (FAT), site acceptance testing (SAT), commissioning and qualification activities.
Assisting with automation testing, alarm management and system verification activities.
Ensuring robust documentation, traceability and handover processes are maintained throughout the project lifecycle.
The successful candidate may be required to support a range of systems, including:
Processing equipment automation.
Cleanroom and environmental control systems.
Autoclaves and sterilisation equipment.
Washers and decontamination systems.
HVAC and critical ventilation systems.
Utility control systems.
Building Management Systems (BMS)
PLC, SCADA and DCS platforms. 
You’ll need to have:

Degree qualified in Automation, Control Systems, Electrical Engineering or a related discipline.
Proven experience delivering automation solutions within pharmaceutical, biotechnology, life sciences, healthcare or other highly regulated environments.
Strong knowledge of PLC, SCADA, DCS and industrial control systems.
Experience supporting commissioning, qualification and validation activities.
Understanding of GMP principles, data integrity and computer system validation requirements.
Experience reviewing design documentation and managing technical interfaces with vendors and contractors.
Excellent stakeholder management and communication skills.
Experience working within sterile manufacturing or aseptic processing facilities.
Knowledge of EU GMP, Annex 1, MHRA or FDA regulatory requirements.
Experience with MES integration and manufacturing digitalisation programmes.
Familiarity with cybersecurity requirements for operational technology (OT) environments.
Chartered Engineer status or progress towards professional accreditation
Only candidates based in UK and eligible to work in UK are allowed