CSV Project Lead

Proclinical is working with a top 20 Pharmaceutical company who though establish, are expanding rapidly and are becoming one of the largest pharmaceutical companies in the world. They are Operating globally and manufacture and distribute drugs out of 60 locations. They are currently looking for additional resources to assist with keeping the quality standards up in their St Louis office.

Our client is looking for a Quality CSV Lead (Computer Systems Validation Engineer) to work on large program of work with their labs. The focus will be to review and process large amounts of data and ensure that it meets quality standards. This will need to then be logged on the correct way according to cGMP documentation practices.

Job Overview:

• Create, maintain, and update all LIMS EM module and CV module master data; including, but not limited to, cleaning, programs, sample types, lists, organisms, instruments, equipment, and classifications.
• Provide support for LIMS projects; including, but not limited to, business and user requirements, consultant support, and master data template building.
• Assist team members and other analysts with troubleshooting instrumentation, LIMS module and other system data, and aberrant sample results.
• Participate in analytical investigations by performing action steps (testing), querying LIMS records, and obtaining other relevant information and documentation to support the investigation process.
• Review and process data, and ensure that it meet specifications, enter data into the computer, maintain instrument logbooks, laboratory worksheets, and all relevant documentation according to cGMP documentation practices, review all information and compile information into report form.
• Occasionally conduct LIMS sampling and testing.

Skills and Requirements:

• Minimum of a bachelor degree (or equivalent) and 0-2 years of experience.
• Previous experience with database administration preferred.
• Previous experience in a manufacturing and/or laboratory setting helpful. However, a combination of experience and/or education will be taken into consideration.
• Position requires knowledge of database structure and administration. Knowledge of Labware LIMS preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 8141 316 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-JE1