Mace is 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.
What we offer:
- Opportunity to work on industry-leading life sciences and advanced manufacturing programmes.
- Exposure to complex, cutting-edge regulated facilities.
- Structured career development and professional accreditation support.
- Competitive salary and benefits package.
- Inclusive, collaborative and high-performing team environment.
Our values
Safety first - Going home safe and well: We champion a safe, diverse and inclusive working environment, understanding the importance of wellbeing in every team.
Client focus - Deliver on our promise: We own the quality of deliverables, strategic outcomes and build long term relationships with our clients.
Integrity - Always do the right thing: We influence positive outcomes within our industry, while always aligning with our compliance obligations.
Create opportunity - For our people to excel: We champion a continuous improvement culture throughout all activities, inspiring our people and teams to develop.
Mace is an inclusive employer and welcomes interest from a diverse range of candidates. Even if you feel you do not fulfil all the criteria, please apply as you may still be the best candidate for this role or another role within our organisation.
We are also open to discussing part time, flexible, and hybrid working options if suitable with-in the role.
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