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CSV Engineer
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a CSV Engineer to be based in Cork on a contract basis.
Job Responsibilities:
- Coordinate validation activities for an MES rollout
- Detailed project planning specific to the validation related activities
- Generation, signoff & execution of various program & GMP related documents and protocols, including a number of the following: validation master plan, URS, FRS/DS, traceability matrix, test specs, IQ, OQ, Integrated OQ & PQ, relevant summary reports and change controls
Skills and Requirements:
- BS or MS in Engineering, Life Sciences, or IT is preferred
- Must have a minimum of 3 years computer systems validation experience
- Familiar with ISA 95
- Experience validating an MES project
- Familiar with SDLC based on GAMP 5
- Previous systems validation experience in a GMP / FDA regulated environment is essential. Exposure to any of the following systems is highly desirable's (Werum, Rockwell PMX or Pharm Suite, Honeywell POMS, XFP etc.)
- Previous experience working as part of a large, multi-disciplinary team completing full project life-cycle implementations
- Excellent technical writing skills
- Strong analytical, problem solving, and interpersonal skills required
- An ability to influence and guide team members when required
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 Badria Kahie on +44 203 8718 094 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.
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