Process Validation Scientist (Limerick)

CareerWise Recruitment

Limerick

PROCESS VALIDATION SCIENTIST required by CareerWise Recruitment for our BioTech client in Limerick, this position is a leadership role within the Process Validation team. The PROCESS VALIDATION SCIENTIST will author, review and approve protocols and reports associated with process validation programs (e.g. process verification/process performance qualification, media/feed/buffer preparation and storage, process intermediate extended hold, chromatography column/filter sanitization and storage, and LIVCA. THE ROLE: * Draft process validation protocols for both process performance qualification and associated studies. * Defines Process Validation Strategies. * Develops and writes protocols for production support activities. * Provides technical expertise (and may facilitate) process risk assessments (e.g. FMEAs). Work collaboratively within multi-functional teams to help ensure that process risks are identified, reviewed and appropriately controlled. * Presents validation data to FDA and other regulatory agencies. * Champion in cell culture and downstream operations for daily monitoring, troubleshooting and investigations. * Performs scientific process investigations with relevant departments as required. * Provide on the floor support to Manufacturing (Cell culture and Purification. * Performs product and process impact assessments. * Participates in or Lead process and quality risk assessments. * Presents findings at group and at interdepartmental meetings. * Communicates information on current process data which may impact Process Validation. REQUIREMENTS: * Experience in process validation within the biotech industry with knowledge of manufacturing processes and biological products preferred. * Bachelor, Master, or Doctorate degree in Life Sciences, Biological/Chemical Sciences, or Process/Chemical Engineering. * A minimum of a BA/BS and a with 5 years relevant experience, MS with 4 years, or PhD with 0-2 years. * cGMP experience is desirable. Please call Conor Twomey today for further information on 021 4297422 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.

1240 days ago