Lead Validation Engineer, SME
|Job Title:||Lead Validation Engineer, SME|
|Contact Name:||Larry O’Leary|
|Job Published:||about 3 years ago|
Our client, a multinational healthcare manufacturing company, now seeks a Lead Validation Engineer who will be focused on Process Validation in an FDA regulated, GMP manufacturing environment. This hire is required to be experienced in ascertaining & managing risk to assigned to elements under review in an FDA regulated, GMP manufacturing environment.
The successful candidate will represent the validation group in projects and other cross functional teams, leading development and execution of Validation related documents throughout the system lifecycle.
The ideal candidate will be an SME in Validation and experienced in applying their knowledge in the development of validation approach and in the presentation, documentation/recording & review of outcome.
This is a long-term staff contract role, based in the Midlands in Ireland.
Requirements for Lead Validation Engineer:
Bachelors Degree qualification in a Science, Engineering or other related field (to level 8).
8 years relevant experience in GMP manufacturing industry, working to FDA regulations.
Experience in the biotechnology and/or pharmaceutical industries is desirable.
Subject matter expert in at least three main areas of validation (Process/Cleaning/ Equipment /Utilities /Facilities/Computer Systems).
Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding.
Practical experience with quality risk management and risk based validation approaches.
Excellent written and verbal communications and technical writing skills.
Proven experience using Microsoft Office Software, with MS Project.
Please phone Larry on 01-2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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Key Words: Pharmaceutical, Development, Process, Process Development, Process Improvement, Tech Transfer, NPI, Validation Engineer, Validation SME, Project Management, GMP, Six Sigma, PAT, Galway, Athlone, Connaught, Leinster, Kildare, Ireland.
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