Life Science Recruitment is hiring for aSenior CSV Specialist to join our clients expanding Life Sciences division.You will join our high-performance team of Technical Engineers and work within an expanding team providing cutting-edge solutions to clients. You will work collaboratively with our customers to scope, plan, implement and refine solutions specific to requirements.

Responsibilities:

• Conception, planning and performing of Computer Systems Validation (CSV) in the regulated environment (Pharma, Medical Devices, Biotech)
• Work directly with our clients to perform gap analysis / early engagement assessments to understand the required scope of full assessments
• Conduct CSV Assessments / Health Checks to assess compliance and report back to senior stakeholders with findings and suggested solutions
• Resolution of fundamental Computer System Validation (CSV) compliance issues derived from implementation of 21 CFR Part 11 automated controls/functionalities in legacy systems
• Ensure all project related issues and deviations are documented and approved
• Ensure computer system validation activities completed are compliant with internal procedures and external regulations and standards.
• Review and approve documents prepared by project teams, other departments and contractor organizations
• Assist in development of validation strategy and validation plan for computer system validations.
• Assist with change control activities in accordance with site procedures
• Support the QA Validation team leader in driving improvements within the Validation and Change Control processes to streamline the validation activities associated with system changes and new technology development.

• Relevant third level qualification or equivalent work experience
• Above 8 years’ Computer System Validation experience including lead experience
• Development and review of computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, Reporting)
• Ability to lead a team of CSV consultants in a consulting environment

• Client-facing skills
• People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
• Team work and emotional intelligence
• Good self-management – continuous performance is both an objective and a mind-set
• Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
• High value on openness and transparency