Cleaning Validation – Executor
About the Company:
Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.
We are now seeking a Cleaning Validation Engineer to support our client based in Co. Limerick.
Location: Limerick
Contract Type: 12 months contract role (Possibility of Extension)
Key Responsibilities:
- Taking Cleaning Validation samples alongside Upstream/Downstream processing.
- Working closely with manufacturing to ensure the CIP/SIP and dirty holds are to the correct times and samples are taken.
- Shows focus & a consistence approach to the role and tasks.
- Excellent people skills
- Experience in aseptic technique
- Experience in Gowning for IOS7/ISO8
- Generating and Executing Validation Protocols.
- Actively look for Continuous improvements
- Experience in Validation specifically cleaning validation
- Experience in assessment of cleaning issues during study runs,
- Experienced Technical writer,
- Experience in Deviation/Change control writing,
- Capable of managing a large program, so project management skills would be necessary,
- An excellent understanding of how manufacturing/Cleaning Validation/Cleaning equipment works
- Understanding of baseline studies for new equipment
- Experienced in coverage testing and clean-into-service
- Generate/review/Approval of CV protocols,
- Generate Reports
- Maintain and update Cleaning Validation Plan
- Schedule of cleaning activities with Manufacturing
- Liaise with numerous departments
- Ensure Training is maintained and current.
- Follow all EHS/Safety SOP/Policies
Preferred Experience:
- Preferred Experience:
- Minimum Level 8-degree in science or related.
- Experienced in QA Validation activities
- Execution of cleaning validation protocols.
- Experience on writing and approving Deviations/ GMP documents
- Technical writing experience in writing site reports.
Note:
•Due to the nature of the business additional duties may be assigned from time to time.
•All applicants must be eligible to work in Ireland.
•All applicants must be willing to work in shifts, if required.
Apply Now
If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.
Apply Now