Automation Engineer

1 month ago

Hatfield Hertfordshire, United Kingdom Planet Pharma Full time

Job Description

Title: Automation Engineer

Location: Hatfield, UK (hybrid)

Type: Permanent full-time.

Purpose

• This role will perform automation engineering activities and manage aligned prioritised projects.

• Lifecycle management of automation systems integrated with manufacturing / packaging equipment.

• Lifecycle management of serialisation and vision systems integrated within packaging equipment including interfaces with enterprise systems.

• 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

• Contribute to the development and implementation of the automation transformation strategy.

• Support the successful implementation of the supervisory control and data acquisition (SCADA) and manufacturing execution system (MES) within the production facility.

• Management of the design, development, maintenance and troubleshooting of automated systems, ensuring they are compliant as per GAMP5 and EU GMP Annex 11.

• Successful delivery of automation projects to meet strategic business objectives.

• Execute or facilitate automation design solutions in accordance with stakeholder requirements and business processes.

• Responsible that all project documentation has been compiled and approved at gate reviews.

• Responsible that Good Engineering Practices (GEP) are employed in the design, installation and commissioning of assets.

• Responsible that Good Manufacturing Practices (GMP) are employed, including activities determined from user requirement specifications (URS) through to qualification.

• Coordination of specialist contractors undertaking work packages, ensuring safe systems of work are adopted throughout implementation phases.

• Support for commissioning, qualification and validation activities.

• Review and approval of GxP documentation, including technical specifications, user requirements, design / code reviews, qualification protocols and site acceptance testing.

• Lead quality and engineering change controls to maintain the validated state of the automated systems.

• System support in the areas of asset management, critical spares, preventative maintenance, training programs and data integrity.

• Provide coaching and development opportunities for the wider engineering / automation teams.

Skills and Qualifications

• Practical experience working within manufacturing and packaging environments – Essential.

• Experience of the automation project lifecycle including design, configuration, implementation, testing, commissioning, troubleshooting and validation – Essential.

• Practical experience working within the pharmaceutical industry – Desirable.

• Practical experience working with Siemens PLCs and HMI software - Desirable.

• Experience of working with SQL databases / Historians – Desirable.

• OT Cybersecurity knowledge – Desirable.

• Practical experience working on SCADA systems – Desirable.

• Practical experience working on MES – Desirable.

• Experience of serialisation / vision systems and interfaces to enterprise systems – Desirable.

• Practical experience working with robotics and/or automated goods vehicles – Desirable.

• Experience working with edge computing / IIoT – Desirable.

• EngTech / IEng / CEng or working towards professional status – Desirable.

• Professional membership (i.e. BCS, IET, ISPE) - Desirable.

• Project management certification (i.e. CAPM / PMP) - Desirable.

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