Duration: 12 Months
Working hours: 39 hours per week
Onsite requirements: Onsite
Engagement Type: Via LTD Company
Legal Right to Work: Applicants must have the legal right to work in the relevant location.
No sponsorship is available for this position.
Atrium Global is supporting a client within the life sciences industry to secure an experienced CSV Engineer for a long-term assignment.
Job Overview
The role focuses on delivering compliant validation activities across computerised systems within a regulated environment.
The successful candidate will support validation planning, execution, documentation and ongoing compliance, collaborating with cross-functional teams to ensure systems meet regulatory and industry standards.
Responsibilities
Develop and execute validation protocols including IQ, OQ and PQ
Create validation plans, test scripts, RTMs and summary reports
Perform risk assessments and impact analyses
Conduct periodic reviews to ensure ongoing compliance
Support change control activities and assess validation impact
Collaborate with IT, QA, Operations and other key stakeholders
Provide CSV guidance and best practice support across projects
Keep up to date with regulatory developments and industry trends
Work with vendors to ensure validated deliverables
Support audit preparation and participate in inspections
Qualify laboratory analytical instruments
Qualify manufacturing automation systems such as DeltaV and MES
Requirements
Degree in Computer Science, Engineering or related discipline
Strong knowledge of FDA 21 CFR Part 11, EU Annex 11 and GAMP 5
Experience in CSV within a regulated pharma or biotech environment
Competence with risk-based validation approaches
Skilled in developing and executing validation documentation
Strong analytical and problem-solving ability with attention to detail
Effective communication and collaboration skills
Ability to manage multiple projects independently
Understanding of SDLC and change control processes
Knowledge of data integrity requirements and application
Seniority level
Mid-Senior level
Employment type
Contract
Industries
Biotechnology Research, Pharmaceutical Manufacturing, and Chemical Manufacturing
#J-*****-Ljbffr