Our medical device client in Dublin requires a Validation Engineer on a permanent basis. Reporting into the NPI Engineer the validation engineer will ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
• Draft and Approve protocols and reports as required.
• Execution of IQ, Process Development, OQ and PQ on new/revised processes as required
• Local use of (BD and Unit level) Validation Toolkits
• Publish site specific progress reports as required.
• Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]
• Create and control PFMEA and control plans throughout product life cycle.
• Participate as required in regular peer reviews of completed validations and advising suggested improvements in practice.
• Assist with Process Development, conduct DOE and MSA.
• Participate in regulatory audits and inspections.
• To link with Post Validation activities including closure of ACR and ECO (Change Control).
• Support site change control procedures.
• Execution of software validation protocols in accordance with site validation procedures and BD toolkits.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Documents software development and/or test development by writing documents, reports, memos, change requests. Methods used are determined by approved procedures and standards.
• Tracks software development effort by creating and maintaining records in the approved tracking management tool.
• Aptitude to understand and apply Medical Device Regulations.
• Third level qualification in relevant area of Engineering / Quality or Manufacturing.
• 2+ years working in Pharmaceutical / Diagnostics / Medical Device manufacture, or equivalent.
• A minimum of 2 years process validation experience
• Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt)
• Software validation experience is desirable particularly in a 21 CFR Part 11 environment.
If you would like further Information you can contact the recruiter directly:
Conor Cronin | Tel: +353 (0) 1 5079258