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Job Title: Senior CSV Engineer – Merignac, France – JO1760

Job ID - 1760

Location: Bordeaux Nouvelle-Aquitaine France FR

Employment Type: Fixed Term

Role

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 are your single end to end partner for consultancy, design implementation, optimisation and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.

We’re looking for dedicated, innovative and driven talent to join our expanding team.

 

“Innovation and change, Join ZT”

 

About the role:

Zenith Technologies are looking for a Senior CSV Engineer to join a Global Pharmaceutical based in Southwestern France near Bordeaux for an initial 6-month contract.

The successful candidate should have a strong Pharma/Bio background with hands on experience in Data Integrity reviews and subsequent Remediation activities of site systems and processes. He/she should be highly motivated, an innovative thinker and self-starter, with excellent interpersonal and problem-solving skills.

 

Responsibilities:

  • Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects. Support and co-ordinate the qualification and validation processes.
  • Ensure that all computer-based systems are operating as intended and meet regulatory requirements.
  • Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) specifically associated with Computer Systems Validations & Data Integrity and as developed and defined in project agreements
  • Support activities include but are not limited to; the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
  • Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects
  • Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.) Participate in required project teams.
  • Responsible for ensuring that the Process Development Manager is consulted on all validation deliverables
  • Conduct validation training with project team communicating deliverables, procedures and methods.

 

Requirements:

  • A minimum of a bachelor's degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech)
  • 7+ years Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
  • Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
  • 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 automation systems.
  • Experience of coordination of Quality documentation and in particular, qualification/Validation documentation.
  • Strong written and verbal communication skills are required.

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