Cache of job #13742535

Job Title

Validation Engineer

Employer

Independent Solutions

Location

Galway

Description

Our client based in Galway is seeking a validation engineer for a 12 month contract. Job Description: Co-ordination, implementation and active participation in the site validation programme. Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project. Develop validation documentation as required (e.g. specifications, plans, protocols, procedures, risk assessments etc.). Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls. Execute qualification protocols as required. Prepare reports of executed protocols. Resolve and assist in the closure of deviations initiated during qualification execution. Co-ordinate re-validation activities. Generate SOP’s / other documentation as applicable. Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements. Design Qualification– validation evaluation, validation plan, DQ protocols, risk assessments, traceability matrices, Part 11 assessment and regulatory review. Regulatory Reviews – reviewing systems for compliance with regulations e.g. Annex 11. Experience & Requirements. Relevant 3rd Level Qualification in science or engineering. Minimum of 3 years direct experience in a validation role in either the medical device or pharmaceutical industry. Strong knowledge of CSV/GAMP, 21CFR Part 11, Annex 11, Project Life Cycle and cGMP Regulations, Outstanding verbal and written communication and presenting skills with the ability to interact with technical and non-technical groups. Adaptable and flexible. Independent Solutions is a professional Irish based limited company with a strong team of full time employees. Our employees come from within the Pharmaceutical Industry with extensive experience. Independent Solutions delivers impartial advice, practical solutions and methodologies to the Pharmaceutical, Biotechnology, Medical Devices and Healthcare Industries. Areas of Expertise: Project Management (PM. Lean Validation/Qualification (Process, System, Cleaning & Equipment. Information Services (IS) /Technology. Regulatory Compliance (EU, FDA and IMB standards. Quality System Implementation/Review (Many ISO standards. Guidelines (GMP, GAMP. Clients include: Wyeth, Pfizer (Newbridge, Dunlaoighre), GlaxoSmithKline (Dungarvan), Almac Clinical Services (Craigavon), Gilead (Cork & Dublin), Gerard Laboratories (Mylan) (Dublin), Time and Data Security (TDS) Citywest, Dublin, Mainstream Renewable Energy (Sandyford, Dublin) Shire Medical (Citywest, Dublin), Vistakon (Limerick),National Pathology laboratories, This job originally appeared on RecruitIreland.com.

Date Added

2502 days ago

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