CPL Life Sciences are partnered with a pharmaceutical manufacturing organisation based out of Hertfordshire in their search for an Automation Engineer.
• 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.
Duties are performed to ensure:
• A safe working environment is maintained for self and other employees, ensuring all near miss incidents and accidents are reported in accordance with procedures.
• The Quality of products manufactured and released is assured through adherence to all procedures.
• Opportunities to improve operations and reduce cost are identified and progressed through the continuous improvement and demand innovation initiatives.
• All stakeholder and customer expectations are understood and met through communication.
• Performance is in line with personal and company objectives with demonstrated behaviours and competencies.
• 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.
For further information please contact [email protected]