Job Title: Cleaning Validation - Executor
Contract role 12 months (Possibility of extension)
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.
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:
- 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.
Job Type: Full-time
Application question(s):
- Are you eligible to work in Ireland without VISA sopnsorship now or in future?
Education:
- Bachelor's (required)
Experience:
- QA : 1 year (required)
- Technical writing: 1 year (preferred)
- GMP : 1 year (required)
- Cleaning validation: 1 year (required)
- CIP / SIP: 1 year (required)
- Aseptic technique: 1 year (preferred)
Work authorisation:
- Ireland (required)
Work Location: In person
Reference ID: INNO R-CVE