Job Description
A Validation Engineer is required by Careerwise recruitment to work with a Clare based biotech company. THE ROLE: * Effectively working within a multidisciplinary team to Prepare, schedule and execute Commissioning, Qualification and Validation protocols * Lead Risk assessments for process and equipment as required. * Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems. * Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors. * Develop protocols for validation projects using a risk-based approach that meets regulatory requirements and industry practices. * Review analyse and interpret system performance data for completed validation and prepare final report packages by summarizing the data. * Investigate deviations, write investigation reports and create summary reports. * Manage equipment vendors to get vendor qualifications scheduled and executed. REQUIREMENTS: * BSc/MSc or BEng/MEng in Engineering or related discipline. * 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof. * Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge. Please call Michael O'Connor today for further information on or email 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. Skills: Validation Engineer Pharmaceutical