Engineering Systems Engineer – ref MQ136

Website HeadcountGroup Headcount Solutions

Headcount Solutions is seeking an Engineering Systems Engineer for our client’s Biologics facility in Meath. Working as part of the Engineering Centre of Excellence, this position will support the Engineering Team and the wider business in the start-up of our client’s facility.

Main Responsibilities:

  • Act as system owner / subject matter expert for Engineering and relevant EHS management systems and standards, including: – contractor management, permit to work, permit office, engineering business continuity plan, environmental management, statutory inspections, mechanical testing programme, emergency response and engineering technical standards.
  • Coordinate and execute gap assessments of current processes against corporate Engineering and EHS standards and industry best practices; identify remediation and ongoing improvement actions and drive to completion.
  • Act as site system owner / subject matter expert for application of corporate engineering and facility design standards to site.
  • Coordinate and execute gap assessments for compliance with the design standards; identify remediation and ongoing improvement actions and drive to completion.
  • Develop and implement safe systems of work for manufacturing and maintenance operations.
  • Implement and support the sites environmental management programme.
  • Support ongoing assessment and improvement of engineering and facility systems against cGMP requirements, including Quality Management System standards and guidelines.
  • Develop and maintain the facility and engineering aspects of the site Business Continuity Plan. Identify and implement process and equipment / facility improvements to control business risks.
  • Support equipment and process introduction and modifications through advising on compliance with engineering / facility design standards as part of the Change Management Process.
  • Lead key sections of the site Emergency Response programme, ensuring the programme is permanently ready for deployment.

Requirements:

  • 3rd level qualification in an Engineering, technical discipline or equivalent.
  • At least 5 years relevant experience in biotechnology, pharmaceutical industry or equivalent.
  • In-depth knowledge of safety and engineering standards and best practices.
  • In-depth knowledge of cGMP regulatory requirements for management of engineering systems and processes.
  • Experience in executing risk assessments.
  • Knowledge of environmental management programmes.
  • Understanding of the principles of Business Continuity and the application to a pharmaceutical manufacturing site.
  • Experience in investigation and problem solving using structured problem-solving techniques.
  • Proven experience in implementing change and project management.

For further information please contact Michael on 086-0435195 or forward details in confidence to [email protected]

 

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