Validation Engineer
CareerWise Recruitment
Waterford
A Validation Engineer is required on a PERMANENET basis by CareerWise Recruitment for our Waterford-based Bio-pharmaceutical and Medical Device Client. The successful candidate will be required to support new product introductions, equipment qualification and the site requalification program. This is a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes. THE ROLE: * Designing, executing and reporting on PV/Process Performance Qualifications. * Designing, executing and reporting on validation studies for equipment, systems and processes. * Ensuring validation studies are managed in conjunction with all required company standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.) * Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation. * Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times. * Maintaining validation documentation through the validation lifecycle. * Participation in external regulatory inspections. * Support Site Change Control process. REQUIREMENTS: * Relevant Engineering or Science qualification. * Previous validation/product development experience would be highly advantageous for the role. * Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations. * Strong working knowledge of statistical techniques. * Awareness of EudraLex GMP Annex 15. * Previous equipment qualification experience and an understanding of the Commissioning and Qualification lifecycle would be advantageous for the role. Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: aohagan-yil@careerwise.ie. CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.
509 days ago