Validation Engineer

Careerwise Recruitment

Donegal

A Validation Engineer is required by CareerWise Recruitment for a leading company based in Donegal. This is to join a New Product Engineering Team to commission and support the introduction of an automation process. THE ROLE: * Co-ordinate all validation activity within the company working directly with the Engineering & Operations Departments. * Lead the project validation team, support the completion of process, systems, software and equipment validations and revalidations in accordance with Validation Master Plans. * Working within the QMS, support the Quality Engineering Team as required. * Provide ongoing guidance and support to all departments relating to process & equipment change control, and the requirements to validate / revalidate. * Ensure ongoing compliance, as applicable, with ISO13485 and other related Guidance Documents (GHTF. * Prepare and review of validation / qualification plans, protocols, reports, and amendments. * Build a strong relationship with internal & external customers by delivering reports/protocols etc. on time per the project plan. * As required, coordinate & discuss validation activity with customers and in line with their requirements. * Represent Validation area at internal audits, external audits, and on cross functional teams including CFTs for risk assessment, CAPA, Continuous Improvement, new product introductions. * Be responsible for the maintenance of the validation procedure and train relevant personnel. * Participate in cross functional teams to establish validation strategies and objectives, determination of sampling techniques and statistical analysis. * Monitor the progress of validation projects on a daily/weekly/monthly basis ensuring that there is continuous drive/focus on meeting schedules. REQUIREMENTS: * Third level qualification to Degree level in Quality, Engineering, Science or related discipline. * Knowledge of validation practices as used within the FDA / ISO 13485 environment. * Knowledge of Quality Standards, Validation Regulations and Guidance Documents required. * Minimum 3 years in a similar role in the medical device industry preferred. * Can work within the QMS using own initiative. Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie. CareerWise Recruitment - In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo ,Cork, Shannon, Galway and Dublin. This job originally appeared on RecruitIreland.com.

2385 days ago