What are the responsibilities and job description for the CSV Workstream Lead position at i-Pharm GxP?
We are seeking an experienced CSV Workstream Lead to lead Computer System Validation activities across a highly automated GMP manufacturing project.
The successful candidate will lead the CSV workstream throughout design, commissioning, qualification, and execution phases, working closely with Automation, CQV, Engineering, Quality, Vendors, and project leadership teams.
This individual will also support the future planning and coordination of CSV execution teams as the project progresses into later execution phases.
Key Responsibilities
- Lead the CSV workstream across the full project lifecycle from design through qualification and operational handover
- Participate in design reviews alongside SMEs, A&E firms, Automation, and Engineering teams
- Lead and/or support generation of:
- GxP Assessments
- URS
- SRA
- DQ
- RTM documentation
- Oversee generation, review, approval, and tracking of CSV deliverables aligned to the master project schedule
- Develop and maintain CSV verification and validation plans aligned to project standards
- Coordinate and manage day-to-day CSV activities across the workstream and associated execution resources
- Ensure CSV deliverables align with CQV activities while minimising duplication of testing efforts
- Manage project risks, issues, dependencies, and stakeholder communication across CSV activities
- Support future execution planning and development of CSV execution team requirements
Technical Environment
Candidates should have strong experience supporting highly automated GMP manufacturing environments including:
- Siemens PCS7
- MES Systems
- Vendor PLC Integration
- Facility Monitoring Systems (FMS)
- Environmental Monitoring Systems (EMS)
- Automated GMP Manufacturing Systems
Requirements
- 10 years of CSV / CQV experience within GMP pharmaceutical or biotech environments
- Strong experience supporting large CAPEX or greenfield manufacturing projects
- Previous Siemens PCS7 and MES experience strongly preferred
- Experience leading CSV strategy, documentation, and execution activities
- Strong understanding of:
- CSV lifecycle
- ASTM E2500 / risk-based validation
- GMP and Data Integrity requirements
- Strong stakeholder management and cross-functional communication skills
- Experience working with electronic validation/documentation systems such as Kneat™ is required.