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
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