QA Cleaning SIP Validation Engineer

Job Type:
Contract
Job Sector:
Engineering
Region:
Europe
Location:
Ireland
Salary Description:
Market Hourly Rates
Posted:
16/11/2018
Recruiter:
Quanta Consultancy Services Ltd
Job Ref:
19490/NK

Job Title:             QA Cleaning Validation (SIP) Engineer
Location:             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:

- 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 requirement: B.Sc, B.Eng.

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Contact Details:
Quanta Consultancy Services Ltd
Tel: (0) 1442 860 521
Contact: Nicolle Kniebe
Email:

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