Tech Transfer Lead (Carlow)

CareerWise Recruitment

Carlow

TECH TRANSFER LEAD required by CareerWise Recruitment for our multinational pharmaceutical client at their vaccine and biologics facility in Carlow. There is an expansion in the Carlow facility at present and this role will manage transfer of a product from a US site. The TECH TRANSFER LEAD will provide process, technical and validation support operations including ongoing support of manufacturing processes and new product introduction. THE ROLE: * Serve as technical leadership and/or validation support as required for manufacturing and new product introduction. * Design/Author/Review/Approve/Execute process development studies, engineering studies, and validation activities in support of new product introduction and ongoing manufacturing support. * Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis and support continuous improvement through Lean Six Sigma methodologies. * Leading and active participation in projects, system failure investigations and investigation reports, Execution/development of change controls, contribution to Kaizen events as appropriate. * Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; * Drive compliance of company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. * Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. REQUIREMENTS: * Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline. * Considerable experience in a comparable role: would typically have experience operating as a senior professional and adding considerable value to the business; in a GMP manufacturing setting. * Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. * Ability to lead/mentor team of engineers. * Report, standards, policy writing skills required in areas of both equipment and process validation. * Sterile filling processes and equipment. * Lean Six Sigma Methodology experience desired. Please call Conor Twomey today for further information on 087-0907204 or email: ctwomey@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.

870 days ago