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-CV

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