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Business Process and Validation Specialist
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A Business Process and Validation Scientist is required on a PERMANENT basis by CareerWise Recruitment for our Cork based Biopharmaceutical Client.
The Business Process and Validation (BPV) 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.
The successful candidate will work to ensure that the process is in-control, capable, compliant and maintained in a validated state. This will be completed through execution of the Annual Product Review (APR) and validation business processes, including authoring of validation protocols and reports. Responsibilities also include authoring documents associated with the technology transfer and subsequent regulatory approval process of products within and across the manufacturing network. The successful applicant will have a deep technical expertise in their area of responsibility and demonstrate strong data-driven decision-making and problem-solving capabilities in a fast-paced cross-functional environment. They will also work to continuously improve business process performance by implementing new processes and process improvements.
* 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 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 audit
* Provide training and mentorship for new personnel
* 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
* An understanding of statistics and usage of statistical tools
Please call Aisling O'Hagan-Yil today for further information on 021- 2427410 or email: firstname.lastname@example.org
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.
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