CSV Engineer DeliveringMES, Automation and Process ControlExcellence
Cognizant Life Science Manufacturing Group operate primarily in Life Sciences; we are world leaders in delivering manufacturing software systems that make businesses compliant and competitive. We specialise in providing Enterprise Performance Solutions comprised of MES, AutomationandProcess-Controlto Life Science companies globally.Working with 9 out of the Top 10 Pharmaceutical and BioTech companies, we partner with customers as an independent trusted advisor, providing performance improvements, reduced costs, total compliance and improved operator effectiveness. We achievethis through combining experienced engineers and consultants, comprehensive design methodologies, and leading edge technology implementation. "Innovation and change, Join Cognizant"
We're looking for dedicated, innovative and driven talent to join our expanding UK team. We are seeking two experienced Validation engineers with exposure to the manufacturing process as applied to the life science industry and in particular pharmaceutical production sphere. One to be based at our office in Warrington, the other based on a customer site in Barnard Castle. Role
- Working within the confines of either Zenith CQV or customer CQV guidelines as the business dictates
- A Key CQV customer point of contact for MES development and deployment program
- Provide CQV MES technical support for multiple pharma manufacturing sites worldwide.
- Co-ordinate and execute training of required personnel on the computer and automation systems validation procedures and methodology
- Keep systems and processes developed for computer and automation systems validation up to date and compliant
- Give guidance on all activities related to computer and automation systems validation
- Support activities include, but are not limited to documentation review and approval Including change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports
- Optimization of CQV support process, including developing standards and KPI reports.
- Ensure standardization and efficiencies across multiple projects
- Compile and analyse validation data and make recommendations for changes and/or improvements
- Maintain all documentation pertaining to computer systems validation
- Participate on cross-functional project teams including development & deployment teams as well as customer Manufacturing, Engineering, Quality and other groups
- Contribute directly to the completion of projects through the management of assigned contract personnel, development and execution of validation change control documents, and development and review of protocols, reports and data tables generated by peers and contract personnel
- Working in a remote team environment (e.g. team members being in geographically dispersed locations).
- Minimum of a Bachelor's degree with a minimum of 5 years of related CSV industry experience (Pharma/Biotech)
- Validation experience with MES and/or other automated systems is preferred
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11
- Strong knowledge of computerized system development life cycle approach is required
- The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required
- Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
- Excellent PC skills with proficiency in either MES or automation systems
- Experience of coordination of Quality documentation and in particular, qualification/Validation documentation
- Strong written and verbal communication skills are required
- *Further details on role available to short listed candidates.