About the OpportunityThis position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning teams, and ensuring regulatory compliance throughout the project lifecycle.
The selected consultant will serve as the primary CSV technical lead, supporting computerized systems and automation associated with manufacturing process equipment from design through commissioning, qualification, startup, and final handover.
What You'll DoAs the Automation / CSV C&Q Technical Lead, you will:
- Lead the Computer System Validation (CSV) strategy for the project.
- Define validation requirements and technical direction throughout the project lifecycle.
- Partner with Process Engineering to ensure automation solutions meet business requirements.
- Provide technical leadership during software development and testing activities.
- Collaborate closely with Design Verification, CQV, Automation Engineering, Operations, Quality, and external vendors.
- Develop and review:
- Validation Plans
- User Requirements
- Functional Specifications
- Design Specifications
- Requirements Traceability Matrices (RTM)
- Test Scripts
- Validation Summary Reports
- Lead execution of IQ, OQ, and PQ protocols for automation and computerized systems.
- Support FAT and SAT activities.
- Manage deviations, investigations, change controls, and validation documentation.
- Develop CSV training plans and training matrices.
- Monitor CSV milestones, schedules, and project deliverables.
- Ensure compliance with GAMP 5, Data Integrity (ALCOA+), cGMP, and company quality procedures.
- Support system turnover to Manufacturing and Operations.
Required Qualifications- Bachelor's Degree in Automation, Controls, Chemical Engineering, Electrical Engineering, Computer Science, or related discipline.
- Significant experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other FDA-regulated environments.
- Experience leading CSV activities on capital projects.
- Strong understanding of:
- GAMP 5
- 21 CFR Part 11
- Data Integrity (ALCOA+)
- cGMP requirements
- Hands-on experience developing and executing:
- IQ/OQ/PQ
- Validation Plans
- RTMs
- Test Scripts
- Validation Reports
- Experience supporting automation platforms and computerized manufacturing systems.
- Experience with technical change management and deviation management.
- Excellent technical writing and documentation skills.
- Strong communication and leadership abilities.
Preferred QualificationsExperience with one or more of the following is highly desirable:
- Large pharmaceutical capital projects
- Automation Lead or CSV Technical Lead roles
- Manufacturing Execution Systems (MES)
- Batch reporting systems
- Data Historians
- Alarm Management
- FAT/SAT execution
- Lilly systems and quality procedures
- Regulatory inspections and FDA audits
What We're Looking ForThe ideal candidate is:
- A technical leader who can influence cross-functional teams
- Highly organized and detail-oriented
- Comfortable working in a fast-paced capital project environment
- Experienced coordinating with engineering firms, automation integrators, contractors, and quality organizations
- Passionate about delivering compliant, high-quality validation documentation
