An Engineering Systems Engineer is required for a biopharmaceutical company in Dunboyne. The incumbent will support the Engineering Team and the wider business in the start-up of their facility in Dunboyne.
- 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.
- Continually monitor industry and corporate policies, procedures, standards and programs; recommend improvements where necessary.
- Liaise with corporate and Ireland-site colleagues on the application of the EHS and engineering standards; take part in cross-site teams to support standardised application across sites.
- 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.
- Act as engineering representative on relevant cross functional site projects.
- Lead key sections of the site Emergency Response programme, ensuring the programme is permanently ready for deployment.
- Provide relevant training and support to colleagues.
- Lead and support relevant site investigations, identifying root cause and measures to prevent recurrence.
Qualifications & Experience:
- 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.
- Experience in the management of safe systems of work.
A good understanding of manufacturing processes, equipment, utilities and maintenance practices.
- 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.
- The ability to think logically and work proactively under pressure.
- The ability to work as part of a team and on own initiative in a constructive manner.
- Excellent verbal and written communication skills.
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