Process Project Engineer
Asset Recruitment View all jobs
- Cork
- Contract
- Full-time
- Participate in the Process Design for Life Science projects for the introduction of new products, equipment, and processes, ensuring all safety, quality, regulatory, and operational requirements are met.
- Develop process estimates, including equipment costs.
- Support process development (as part of technical transfer), troubleshooting, and optimization.
- Collaborate with cross-functional design teams to ensure accurate completion of detailed designs, on time and within budget.
- Work with cross-functional teams during project planning and deployment, including collaboration with supporting departments such as Technical Development, Production/Operations, Quality, Safety, Facilities, and Engineering. Conduct process mapping and gap analysis for new and existing pharmaceutical manufacturing processes.
- Specify equipment, design processes, and support commissioning as required.
- Develop and manage change control processes for the project.
- Coordinate design changes using the client-approved change control procedure to ensure compliance with cGMP.
- Generate, review, and approve project documentation (Scope, User Requirement Specifications, etc.).
- Supervise junior process engineers when projects require additional support.
- Support validation activities for project deliverables, including reviewing validation documentation and participating in validation activities (FAT, IQ, OQ, etc.).
- Provide technical support to end users of new and existing equipment, including troubleshooting technical issues and assisting with process investigations.
- Attend HAZOP sessions and manage the closeout of HAZOP recommendations.
- Update existing Hazardous Area reports for equipment and processes.
- Create, review, and approve site engineering specifications and other documents as required, ensuring accuracy and compliance with standards.
- Provide technical updates to Standard Operating Procedures (SOPs) related to equipment or process changes.
- Participate in all training and assessment activities related to the role.
- Record and report any process changes related to projects that could impact budget or schedule.
- B.Eng in Chemical or Process Engineering, or an appropriate science or engineering discipline.
- 8+ years of recent, relevant experience in a process engineering role in the pharmaceutical, chemical, or biotech industry.
- Understanding of secondary pharmaceutical manufacturing processes, e.g., fill lines.
- Proven track record in process design, development, support, and improvement.
- Good understanding of ATEX and hazardous area zoning.
- Ability to organize, plan, and execute multiple tasks within tight schedules.
- Flexibility and ability to adapt to changing priorities.
- Proven experience with process-based activities in the pharmaceutical industry.
- Familiarity with process technologies and equipment procurement.
- Excellent communication skills and a creative approach to problem-solving.
- Excellent leadership skills and the ability to work both independently and in cross-functional team environments.