Title: Automation Engineer
Location: Hatfield, UK (hybrid)
Type: Permanent full-time.
Purpose
1. This role will perform automation engineering activities and manage aligned prioritised projects.
2. Lifecycle management of automation systems integrated with manufacturing / packaging equipment.
3. Lifecycle management of serialisation and vision systems integrated within packaging equipment including interfaces with enterprise systems.
4. Responsible for providing cGMP compliant control systems as per GAMP5 and EU GMP Annex 11.
General Responsibilities (Safety, Quality, Customer, Cost and Innovation)
To ensure that operations conducted are performed in accordance with the requirements of corporate standards, quality system, cGMP and GDP guidelines and industry standards.
Job Specific Responsibilities
1. Contribute to the development and implementation of the automation transformation strategy.
2. Support the successful implementation of the supervisory control and data acquisition (SCADA) and manufacturing execution system (MES) within the production facility.
3. Management of the design, development, maintenance and troubleshooting of automated systems, ensuring they are compliant as per GAMP5 and EU GMP Annex 11.
4. Successful delivery of automation projects to meet strategic business objectives.
5. Execute or facilitate automation design solutions in accordance with stakeholder requirements and business processes.
6. Responsible that all project documentation has been compiled and approved at gate reviews.
7. Responsible that Good Engineering Practices (GEP) are employed in the design, installation and commissioning of assets.
8. Responsible that Good Manufacturing Practices (GMP) are employed, including activities determined from user requirement specifications (URS) through to qualification.
9. Coordination of specialist contractors undertaking work packages, ensuring safe systems of work are adopted throughout implementation phases.
10. Support for commissioning, qualification and validation activities.
11. Review and approval of GxP documentation, including technical specifications, user requirements, design / code reviews, qualification protocols and site acceptance testing.
12. Lead quality and engineering change controls to maintain the validated state of the automated systems.
13. System support in the areas of asset management, critical spares, preventative maintenance, training programs and data integrity.
14. Provide coaching and development opportunities for the wider engineering / automation teams.
Skills and Qualifications
1. Practical experience working within manufacturing and packaging environments – Essential.
2. Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning, troubleshooting and validation – Essential.
3. Practical experience working within the pharmaceutical industry – Desirable.
4. Practical experience working with Siemens PLCs and HMI software - Desirable.
5. Experience of working with SQL databases / Historians – Desirable.
6. OT Cybersecurity knowledge – Desirable.
7. Practical experience working on SCADA systems – Desirable.
8. Practical experience working on MES – Desirable.
9. Experience of serialisation / vision systems and interfaces to enterprise systems – Desirable.
10. Practical experience working with robotics and/or automated goods vehicles – Desirable.
11. Experience working with edge computing / IIoT – Desirable.
12. EngTech / IEng / CEng or working towards professional status – Desirable.
13. Professional membership (i.e. BCS, IET, ISPE) - Desirable.
14. Project management certification (i.e. CAPM / PMP) - Desirable.
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