Ascend PM are hiring a Process Engineer to join our clients team, a pharmaceutical company based in West Dublin. This is a great Contract opportunity to join a growing team. Contact or email CV to clairebrogan@ascendpm.ie to find out more
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 process engineer plans and manages day-to-day technical support and planned and unplanned work on process and associated
equipment including facility support to meet manufacturing or plant shutdown schedules while maintaining a high level of GMP compliance and being cost efficient. The process engineer is also responsible for the requalification and life cycle management of the qualified equipment onsite. The process engineer will also be responsible for supporting the identification and implementation of continuous process improvements.
Key Responsibilities
• The position requires effective cross-functional collaboration with internal partners including Site Engineering, Facilities Management, Manufacturing Operations, Technical Operations, and Quality and external contractors.
• Manage all process engineering activities and utility activities to meet and optimize manufacturing schedules while maintaining a high level of GMP compliance and cost efficiency.
• Manage process engineering activities includes all planned and unplanned works on process equipment.
• Corodinates with maintenance all utilities equipment activities including all planned and unplanned works on utility equipment associated with the clean areas.
• In addition to vendor training provide training to the process and utility technicians on process equipment.
• Collaborate with the maintenance and utlities lead to optimise the preventative maintenance program across process and utility systems including a review of executed maintenance activities and identify improvements to the maintenance job plan content.
• Implement equipment and maintenance reliability improvements. Development and implementation of area / equipment improvement plans to repeat failures and other maintenance problems.
• Life cycle management of the validation of qualified equipment and ongoing process engineering support for this equipment.
• Provide support to Manufacturing, Validation, and Maintenance on process equipment and utility systems when required.
• Manage all process engineering and validation activities associated with qualified equipment on site.
• Coordinate with quality and other areas on the requalification program.
• Manage vendors supporting/executing the works.
• Provide Engineering expertise in trouble shooting activities to support manufacturing during process transfer activities or deviation investigations.
• Provide support and participate in regulatory inspections.
• Lead and support system improvements, development of specifications, engineering documents and standard operating procedures.
• Identify and support process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing support equipment.
• In conjunction with approved vendors, research new processes and/or systems for maintenance/manufacture of equipment and implement new processes and systems as developed under the direction of the Operations Manager.
• Acts as an advocate for engineering continuous improvement activities.
• Ownership and tracking of engineering key performance indicators (KPI’s) for the utility areas.
• Take the lead in troubleshooting and problem solving on process equipment while providing coaching and mentoring to other engineering, maintenance and operations staff.
• Lead technical root cause analysis, incident investigations and troubleshooting issues related to utility equipment/systems.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Promote regulatory compliance and alignment of the site with the Business Unit Engineering strategies and objective.
• Ensure a commitment to safety, quality and operational excellence at a competitive cost. Understand system reliability and availability and manage any scheduled or unscheduled down-time and the associated risk.
• Participate in the on call process 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 working in a technical engineering role in the Pharmaceutical / Biotechnology industry.
• Evidence of continuous professional development.
• Team leadership experience.
• Experienced in identifying priorities for assignment of resources and time.
• Experienced in the application of lean principles and structured problem-solving techniques.
• Strong technical capabilities, communication skills, teamwork abilities and initiative.
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Organized analytical thinker with strong attention to detail
• Excellent oral and written communication skills, including technical writing
• Demonstrated ability to work effectively with vendors and resolve issues in a timely and structured manner.
• Must have good verbal and written communication skills. Ability to present and explain data to both technical and non-technical forums.
• Collaborative teamwork philosophy and demonstrated positive interaction with others.
• Mature judgment in problem solving situations.
• Independent decision-making abilities with strong results orientation mindset.
• Rigorous attention to detail.