Job Description
Our client, a multinational healthcare manufacturing company, seeks a Validation Engineer who will be responsible for the design and execution of validation documents, programs and strategies to support the implementation of the Validation Master Plans at the facility.
The successful candidate will provide validation mentoring, support and expertise in the definition, development and test of the complete validation lifecycle for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification. The hire will also drive the execution of validation and qualification activities.
Responsibilities for Validation Engineer:
Leading & coordinating Site Validation projects as required.
Represent the group in production meetings and cross site meetings.
Review of validation / qualification plans, protocols, reports, amendments and other validation / qualification records across test, software, process, systems and equipment validations.
Design, develop, debug, modify, and validation lifecycle documents and procedures, systems by using current tools, analysis techniques, and technologies.
Leading & coordinating Site Validation projects as required
Execute and complete test, software, process, systems and equipment validations and revalidations in accordance with Validation Master Plans.
Maintains detailed documentation through all phases of development, testing and analysis in the tracking databases and systems.
Work with cross functional groups to improve lean efficiency?s and validation timeline efficiency?s and reduction in production downtime.
Provide site training for test method validation, process validation and facility, utility and equipment qualification.
Takes ownership of the Software Quality Tasks within the Electronic and Manufacturing teams.
Work closely with developers who are testing Test and Manufacturing technologies
Develops test framework and test cases, collaborates with cross functional groups to create and maintain a continuous improvements for test, manufacturing systems and automation.
Qualifications & Experience
Honours Bachelors (Level 8) Degree in Electronic, Electrical or Software Engineering or the same in Science.
5 years industry experience, validation lifecycle experience and proven problem solving abilities.
A strong background in software, test & automation is required.
Ideally you have experience understanding code (ideally C, C#, Labview).
Knowledge in regulated documentation lifecycle environment and have experience in electrical testing of electronic and mechanical devices is preferred.
Please contact Larry on 01-2302400 / larry@rftgroup.ie / www.rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
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