Senior CSV Engineer - Day-Rate Contract
Global Biopharma - Expansion Programme
Our client, a rapidly growing global biopharmaceutical organisation, is seeking an experienced Senior CSV Engineer to support major upgrades across manufacturing, QC and enterprise systems. This day-rate contract offers the chance to play a key role in strengthening compliance and digital capability within a highly regulated environment.
The Role
You will lead the validation of complex computerised systems, ensuring they meet regulatory expectations and align with internal quality standards. Working closely with Quality, IT, Operations and external suppliers, you will oversee the full lifecycle of validation activity-from risk assessment and protocol development to execution, documentation and inspection readiness. The position covers a broad mix of laboratory instrumentation, server-based applications and enterprise platforms, making it well suited to a seasoned CSV specialist.
Key Responsibilities
- Develop and execute IQ, OQ and PQ protocols for computer systems and analytical instruments.
- Produce and maintain validation documentation, including plans, test scripts, traceability matrices and summary reports.
- Complete risk assessments, including ERES and Data Integrity evaluations.
- Support change control, assessing system impact and defining required validation.
- Provide CSV guidance across project teams and contribute to audit and inspection preparation.
- Validate laboratory and enterprise systems such as LIMS, Empower and NuGenesis, as well as middleware and database-driven applications.
- Use paperless validation tools such as ValGenesis, Kneat or ALM.
- Qualification of analytical equipment including cell viability analysers and liquid handlers.
Experience & Background
- Degree in Computer Science, Engineering or related discipline.
- Strong understanding of FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
- Minimum five years' experience in CSV within pharma or biotech.
- Skilled in SDLC, risk-based validation and data integrity principles.
The Next Step for you:
Should this position be of interest to you please forward your CV to Sarah Mac Mullan from Next Generation Recruitment or alternatively call on the main line on 00 353 1 6498546
Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical and Operation (permanent, contract and temporary) positions.
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