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VALIDATION ENGINEER

 

Company:

PHARMA-BIO SERV
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Job Reference Number

14566610

Client ID:

RI/PBSV587
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Posted On:

Feb 7 2012

Location:

MUNSTER, CORK
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Job Type:

Contract/Permanent

Salary:

COMPETITIVE SALARY/RATE
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At Pharma-BioServ, we are recruiting an experienced Validation Engineer to join our existing team of consultants working for a medical devices company in Cork.


Role/Opportunity

  • Generate and review validation documents (URS, RA, VP, IQ’s, OQ’s & PQ’s)
  • Execute validation protocols and generate reports and ensure they are completed in accordance with procedure and cGMP’s.
  • Participate in performance of Risk Assessments.
  • Participate in the design of FMEAs and prepare executive summary reports for FDA submissions.
  • Collaborate with Engineering, Operations and Quality in the execution of the protocols.
  • Oversee the specification, completion, and reporting of all internal and external analytical testing required by validation protocols.
  • Establishment of solution testing procedures to be used in production.
  • Resolve any deviations associated with protocol execution.
  • Strong project management skills
Skills/Experience

  • 3rd Level Degree qualification in a Mechanical/Science Discipline.
  • At least 4 years validation experience in a highly regulated environment.
Pharma-Bio Serv is a Regulatory Compliance and Validation Consulting Service provider, with locations in Cork Ireland, Philadelphia, USA and Puerto Rico . Over the past 18 years, we have established a broad base of compliance related services, currently focused on the effective and optimized leveraging of Quality Risk Management Strategies. Our goal is to provide our partners with insightful and robust compliance solutions, that have a direct impact on your business.

To apply for this role, send your updated CV to smanley@pharmabioserv.com or call Sarah Manley on 021-4619034/0867952010 for an initial and confidential discussion.