Job Title: CSV Engineer
Job ID - 2080
Location: Rutherford House, Warrington Rd Birchwood Warrington UK United Kingdom Cheshire WA3 6ZH
Employment Type: Permanent
Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services. Operating across 5 continents and with over 850 skilled employees, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market.
We’re looking for dedicated, innovative and driven talent to join our expanding UK team. We are seeking an experienced Validation Engineer with exposure to the manufacturing process as applied to the life science industry and in particular pharmaceutical production sphere.
- 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
Apply through this link or send your CV referencing job order JO2080 to UKRecruitment@zenithtechnologies.com
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