We are seeking a Cleaning Process Engineer to support cleaning validation and operational readiness within a leading pharmaceutical manufacturing site in Cork. The successful candidate will contribute to the development, optimisation, and documentation of cleaning processes across automated and manual systems, ensuring compliance with regulatory and quality standards.
Key Responsibilities
* Develop and optimise cleaning strategies for pharmaceutical equipment and systems in alignment with GMP and regulatory requirements.
* Author and review cleaning instructions, SOPs, and batch documentation for operational staff.
* Collaborate with process, automation, and operations teams to integrate cleaning requirements into automated control systems.
* Support cleaning validation activities, including design of validation studies, execution oversight, and data analysis.
* Troubleshoot cleaning-related issues and propose sustainable technical solutions.
* Provide technical support to operators and training where required.
* Contribute to continuous improvement initiatives to enhance cleaning efficiency and reduce downtime.
* Participate in cross-functional project teams, ensuring cleaning deliverables are met on schedule.
Qualifications & Experience
* Degree in Chemical Engineering, Process Engineering, Pharmaceutical Science, or a related field.
* 3+ years' experience in a regulated pharmaceutical or biopharmaceutical environment (experience with cleaning processes an advantage).
* Strong technical understanding of automated systems and process control.
* Experience in writing technical documentation such as SOPs or work instructions.
* Familiarity with GMP regulations and industry cleaning validation requirements.
* Excellent problem-solving, organisational, and communication skills.
Desirable
* Experience with cleaning validation lifecycle management.
* Knowledge of automated manufacturing systems (DeltaV, SCADA, or similar).
* Prior experience supporting manufacturing operations in a project environment.