At a Glance
- Tasks: Lead automation projects in a dynamic pharmaceutical environment and ensure compliance with industry standards.
- Company: Join a top engineering consultancy known for innovation and excellence in the life sciences sector.
- Benefits: Attractive salary package, career development opportunities, and a chance to work on impactful projects.
- Other info: Collaborative team environment with opportunities for professional growth and learning.
- Why this job: Make a difference in healthcare by enhancing automation in sterile manufacturing processes.
- Qualifications: Degree in Automation or related field with experience in regulated industries.
The predicted salary is between 50000 - 70000 Β£ per year.
- Project Engineer β Automation
- 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.
Responsibilities
- 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.
- Systems you may support
- 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.
Skills and Experience
- 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.
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Project Engineer - Automation employer: People Group Limited
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