We are currently seeking a Process Engineer to support a key pharmaceutical manufacturing site in Cork. The successful candidate will take responsibility for planning, executing, and continuously improving the production cleaning processes across API equipment and process trains. A strong technical background in API manufacturing is highly desirable, with proven ability to author cleaning instructions to meet regulatory standards.
Key Responsibilities:
- Lead the planning and execution of equipment and process cleaning activities
- Conduct Morning and Evening Handover meetings during Cleaning cycles
- Ensure cleaning activities are completed on schedule and in line with business objectives
- Drive improvements in Cleaning cycle times; identify and resolve bottlenecks
- Prepare all relevant documentation (Tickets, Visual Boards, Campaign Summaries, etc.)
- Track and analyse cleaning progress and downtime to inform future improvements
- Ensure availability of equipment and consumables ahead of cleaning activities
- Lead or contribute to After Action Reviews for Cleaning
- Benchmark and implement best practices in Cleaning based on industry trends
- Support training and upskilling of Process and Operations teams on Cleaning best practices
- Generate Cleaning Campaign Summaries for key stakeholders
- Identify and lead continuous improvement projects to enhance cleaning efficiency
- Assist Operations leadership in daily scheduling and coordination of Cleaning activities
- Collaborate with Maintenance Planners to align PMs and Work Orders with Cleaning schedules
- Provide technical troubleshooting support for equipment and processes during Cleaning
- Participate as an active member of the Small Molecule Cleaning Process Team (weekly meetings)
- Write non-routine Cleaning instructions as required
- Conduct non-routine sampling during Cleaning processes
- Drive Lean initiatives and process improvements related to Cleaning activities
Key Skills & Attributes:
- Strong technical knowledge of processing equipment and Cleaning regimes (chemical cleaning, recirculated washing, etc.)
- Solid understanding of API / Small Molecule manufacturing and production scheduling
- Demonstrated experience in writing clear, regulatory-compliant Cleaning instructions
- Passion for continuous improvement and process optimisation
- Experience in standardising business systems across Small Molecule operations
- Strong data-driven mindset with the ability to analyse Cleaning performance metrics
Candidate Profile:
- Minimum 3 years of experience in a pharmaceutical manufacturing environment (API experience preferred)
- Comfortable working in a highly regulated environment with strict GMP compliance
- Proven track record of driving process improvements and achieving efficiency gains
- Excellent communication and leadership skills to coordinate cross-functional teams
