SIP Validation Engineer

Sectors:
Chemicals, Inspection & testing labs
Locations:
Republic of Ireland
Qualifications:
Not specified
Contract type:
Interim, contract & temporary
Hours:
Full time
Salary description:
Competitive
Sub-sectors:
All
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Posted:
12/10/2018
Start Date:
ASAP
Recruiter:
Quanta Consultancy Services
Job Ref:
542365772

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

Our Biopharmaceutical Client are 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: 2+ years 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.

Closing Date:
09/11/2018
Contact Details:
Quanta Consultancy Services
Contact: Nicolle Kniebe

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