Job Title: Cleaning Validation Engineer (Dublin)
About the company: Innopharma Technical Services, part of Innopharma Group, specialise in the provision of highly skilled resources for Life Sciences industries.
We are currently seeking a highly skilled Cleaning Validation Engineer to join our Biopharmaceutical manufacturing client in Dublin.
About the Position:
The successful candidate will be responsible for designing, implementing, and overseeing cleaning validation processes to ensure compliance with regulatory standards and maintain product quality.
Key Responsibilities:
• Developing cleaning validation strategies and annual revision of cleaning validation master plan.
• Managing multiple cleaning validation studies running in parallel.
• Generation of Cleaning validation protocols, including, sampling strategy, VAC generation, VI’s and sampling, co-ordination of sample analysis and generation of Validation Summary Reports.
• Investigate and conduct troubleshooting/root cause analysis of cleaning-related incidents and deviations.
• Provide technical support for cleaning activities associated with the manufacturing process
• Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) for cleaning sampling activities
• Review and approve Manufacturing Cleaning Working Instructions and Forms
• Support periodic review of cleaning validation studies
• Train manufacturing and QC/QA personnel on cleaning validation documentation
• Liaising with manufacturing re CIP/SIP, dirty hold times requirements.
• Capable of managing a large program, so project management skills would be necessary,
• An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment
works
Preferred Experience:
• BSC in science or engineering related discipline
• 4 years experienced in Cleaning Validation activities.
• Ability to work independently and on multidisciplinary teams.
• Excellent oral and written communication.
• Compliance focussed with a right first-time approach.
