Description
Job Title: QA Cleaning Validation (SIP) EngineerLocation: Munster Province, Ireland
Biopharmaceutical Organisation looking for a cleaning/SIP Validation Engineer to Complete Document Preparation and Field Execution activities for the Cleaning Validation Program on site.
JOB DUTIES:
- Experience in Validation specifically cleaning validation and thermal mapping
- Experience in assessment of cleaning issues during study runs,
- Placement of thermocouple probes in vessel and transfer lines
- 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/Thermal mapping works
- Troubleshooting of thermal mapping studies for investigation and Engineering studies
- Understanding of baseline studies for new equipment
- Experienced in coverage testing and clean-into-service
- Generate/review/Approval of CV/SIP protocols,
- Generate Report
- Maintain and update Cleaning/Steam in place Validation Plan
- Schedule of cleaning/SIP activities with Manufacturing
- Liaise with numerous departments
JOB REQUIREMENTS:
Skills and abilities required to perform the job.
- Proven Biotech experience in the given area, as follows:
- Validation engineer position: MUST HAVE Biotech cleaning/SIP validation experience
- Experience in Document Preparation and Execution
- Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning and SIP validation studies may be concurrent activities in different trains.
- Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing.
- Have Troubleshooting and analytical mindset.
Educational requirements: B.Sc, B.Eng.