Ascend PM is hiring a Process Engineer for a pharmaceutical company based in West Dublin.
This is a great contract opportunity to join a growing team.
Contact or email CV to ****** for more information.
Summary
Reporting to the Engineering Services Lead, the Process Engineer is the primary owner for process equipment within the clean room areas and associated utility systems in a GMP regulated manufacturing setting.
The role plans and manages day-to-day technical support and both planned and unplanned work on process and associated equipment, including facility support to meet manufacturing or plant shutdown schedules while maintaining high levels of GMP compliance and cost efficiency.
The Process Engineer is also responsible for the requalification and life-cycle management of qualified equipment on site, and for supporting the identification and implementation of continuous process improvements.
Key Responsibilities
Collaborate with internal partners such as Site Engineering, Facilities Management, Manufacturing Operations, Technical Operations, and Quality, as well as external contractors.
Manage all process engineering activities and utility activities to meet and optimise manufacturing schedules while maintaining GMP compliance and cost efficiency.
Plan and execute all planned and unplanned work on process equipment and coordinate with maintenance on utility equipment associated with clean areas.
Provide training to process and utility technicians on equipment operations.
Work with the maintenance and utilities lead to optimise the preventive maintenance program across process and utility systems.
Implement equipment and maintenance reliability improvements through development and implementation of improvement plans.
Oversee the validation of qualified equipment and provide ongoing process engineering support.
Provide support to Manufacturing, Validation, and Maintenance on process and utility systems as required.
Coordinate with quality and other departments on requalification programmes.
Manage vendors supporting or executing works.
Act as engineering expertise in trouble-shooting activities to support manufacturing during process transfers or deviation investigations.
Participate in regulatory inspections and support a safe working environment by complying with all relevant EHS practices and regulations.
Lead and support system improvements, development of specifications, engineering documents, and SOPs.
Identify and support process optimisation initiatives and address opportunities for efficiency and capacity improvements.
Research new processes and systems with approved vendors and implement new processes and systems as directed by the Operations Manager.
Advocate for continuous improvement activities and track engineering KPIs for utility areas.
Tackle troubleshooting and problem-solving on process equipment while providing coaching and mentoring to engineering, maintenance, and operations staff.
Lead technical root cause analysis, incident investigations, and troubleshooting related to utility equipment/systems.
Maintain a commitment to safety, quality, and operational excellence at a competitive cost, managing scheduled or unscheduled downtime and associated risk.
Serve on the on-call rotation when rostered with oversight and responsibility for all site activities out of hours.
Education / Experience / Skills
A third-level degree in Process Engineering or equivalent experience.
Relevant experience in a technical engineering role within the Pharmaceutical/ Biotechnology industry.
Evidence of continuous professional development.
Team leadership experience.
Experience prioritising assignment of resources and time.
Experience applying lean principles and structured problem-solving techniques.
Strong technical capabilities and communication skills with initiative.
Ability to work effectively with vendors and resolve issues promptly and structurally.
Organised analytical thinker with strong attention to detail.
Excellent oral and written communication skills, including technical writing.
Ability to present and explain data to both technical and non-technical forums.
Collaborative teamwork philosophy and positive interaction with others.
Mature judgment in problem-solving situations.
Independent decision-making abilities with a strong results-orientation mindset.
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