Process & Validation Scientist

PROCESS AND VALIDATION SCIENTIST with an understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification and Annual Product Reviews required by CareerWise Recruitment for our multinational Biotechnology client in Co. Cork, this is a permanent role. The PROCESS AND VALIDATION SCIENTIST will be responsible for providing technical support for existing manufacturing processes as well as aspects of the development, commercialization and technology transfer of new processes into the operations/manufacturing environment.

Role of this position

• Understand the purpose and science of the process; have an in-depth knowledge of the science (including analytical) behind the molecule and the process. Understand the process control strategy (upstream/cell culture and downstream/purification) for biotech drug substance processes.
• Anticipate and resolve complex problems during the planning, authoring and execution of process validation protocols/studies and associated reports for Lilly's products. Establish relationships with key stakeholders both within and outside the TS/MS function. Provide data and collaborate with manufacturing TS/MS and Statistics groups in support of data trending and the establishment of process limits including assessments of process control and capability and maintenance of validated state.
• Coordinate Annual Product Reviews (APRs) and author relevant TS/MS sections of APRs. Liaise with senior technical molecule stewards and cross-functional stakeholders to ensure processes remain in control, capable and compliant.
• Author technical documentation supporting technology transfers and product commercialization activities. Work collaboratively with the Subject Matter Experts (SMEs) and the Regulatory Affairs CMC organization to contribute to the authorship and review of technical content for regulatory submissions and responses to regulatory agencies.
• Review protocols and technical reports, both within and external to TS/MS.
• Leads/authors technical investigations, deviations and change controls within the Trackwise system.
• Leverage internal and external expertise to improve existing business processes, and lead/participate in implementation of initiatives. Makes decisions that impact a range of standard and non-standard operational, process, or project activities.
• Understand and ensure compliance with safety and regulatory expectations.
• Provide technical support during regulatory audits.
• Provide training and mentorship for new personnel.

JOB REQUIREMENTS

• MSc/PhD in Biochemistry, Cell Biology, Biotechnology, Microbiology, Analytical Science, Biochemical Engineering, or related discipline.
• Greater than 3 years experience in a pharmaceutical manufacturing environment is preferable.
• An understanding of key TS/MS deliverables such as Tech Transfer, Process Monitoring, Process Validation, On-going Process Verification, Annual Product Reviews.

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.