Summary of Role
The Senior CSV Engineer will operate with the Odyssey Validation Consultants project teams in performing GxP Computerised Systems CSV, Consulting and Project Management activities.
Main Responsibilities & Duties
- Management of client CSV activities and relationships
- Working as part of client project teams to define CSV strategy for projects
- Delivering front end consultancy services as part of ongoing business development
- Managing junior and mid-level resources on client projects and managing the training and upskilling needs of those resources
- Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems.
- Review/Approval of all GxP Computerised Systems Validation Documentation.
- Administration of GAMP lifecycle across concurrent projects.
- Any other duties which may be assigned from time to time.
- Working as part of Odyssey VC and client teams in the development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems.
- Have the ability to communicate IT/Validation concepts/strategies to project teams.
- Be a self-starter and be motivated to provide a solid product quality and customer experience.
- Be adaptable to a fast pace working environment
- Be able to integrate and interact well within the customer environment.
- Have excellent communication and interpersonal skills, both written and verbal
- Have excellent Microsoft Office user level skills
- Excellent knowledge of change management processes and the development of standard operating procedure.
Education & Experience
- A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 10 years’ relevant experience).
- A minimum of 10 years CSV experience in the Life Sciences sector
- Project management qualification preferred but must have a history of managing multiple concurrent projects
- Excellent communication and interpersonal skills
- Detailed knowledge of regulatory guidance documents and standards
How to Apply : Email your CV and cover letter to firstname.lastname@example.org with reference:OVC-CSV-SNR
This profile is a guideline for the role and may develop or change in accordance with the individual, their manager or business demands.