Description
Role – CSV - Subject Matter ExpertType - initially 12 month contract
Location – UK, North West
Summary
One of our key clients, a global leader within biopharmaceuticals is looking for an SME within the Computer System Validation field, to provide their expertise on one of their biggest start-up projects currently in the UK.
Key Responsibilities:
- Provide specialist knowledge to the project starting from the early scheme design stages through to detailed stages and testing (validation and execution)
- Review of all documents (FAT/SAT) and development plans, advising on any changes/improvements.
- Be the SME within the field advising the client’s own Automation Team and assist the Validation Manager on any decisions.
- Drive User Requirement Spec (URS) and SIA (System Impact Assessment) approval.
- Generate Equipment Qualification Assessments (EQAs) and subsequent IQ, OQ and where necessary PQ,
- Execute IQ, OQ and where necessary PQ protocols and drive post-approval of same.
- Support the client Management in Project delivery.
Key Requirements:
- Strong background within the project delivery within the Biopharmaceutical/Pharmaceutical environment
- Experience in Document Preparation and Execution
- Experience in major start-ups where construction and involvement in the full project life cycle
- Knowledge and experience in most main systems used such as Delta V, Siemens, PLCs, SCADA etc
- Good technical knowledge of equipment and the concepts of BioTech manufacturing.