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
Overview:
We are seeking an experienced Process Engineer to join our clients team, working collaboratively with Global Device Engineering (GDE) and Manufacturing to design and implement advanced, high-performance manufacturing processes for medical device production. This role involves active participation in multiple projects focused on the development, automation, and testing of medical devices, taking process and equipment concepts through to full-scale implementation on the manufacturing floor.
Key Responsibilities:
• Design and develop robust, high-yield manufacturing processes that ensure consistent product quality
• Optimize equipment and process technologies to support the successful transfer of reliable, efficient processes into full-scale manufacturing.
• Collaborate with GDE teams to support the design and seamless transition of new medical devices from development through validation and into production.
• Manage and support external vendors in the design, build, and installation of manufacturing equipment-from initial concept through to factory integration.
• Drive continuous improvement and innovation in existing equipment and processes to support New Product Introductions (NPIs).
• Prepare and maintain detailed process and manufacturing documentation.
• Author and execute validation and qualification protocols (IQ/OQ/PQ) for equipment and processes.\
• Champion ongoing process improvement initiatives to ensure high standards of product quality and efficiency.
• Coordinate with cross-functional teams to support both current and future manufacturing needs.
• Act as a site-level expert in specific manufacturing technologies and support knowledge development within the team.
• Oversee the commissioning and scaling of new manufacturing technologies, with a focus on microcatheter production.
• Conduct risk assessments with Environmental Health & Safety (EHS) teams when introducing new equipment, materials, or chemicals to reduce environmental impact
Education & Experience
• Bachelor’s degree (Level 8) in Engineering or Science (Manufacturing, Mechanical, Electronic, Production, or related disciplines).
• Minimum of 5 years of experience in the medical device industry.
• Strong understanding of medical device regulations including FDA standard 21 CFR Parts 801 and 820, design controls, ISO13485, regulatory audits and international environmental regulations. Extensive experience and track record of success in the development of 510K/PMA regulated products required.
• Excellent analytical and problem-solving capabilities
• Possesses interpersonal skills to negotiate and reconcile differences, while optimizing overall business goals
• Excellent written and verbal communications skills with strong competency in MS Office tools and Project management applications.
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.
