CSV Analyst (R&D) / Lead Validation Engineer
A fast-growing consultancy in the life sciences industry is hiring an CSV Analyst to lead validation efforts for R&D IT systems. This role is ideal for experienced professionals with strong computer system validation (CSV) and software development lifecycle (SDLC) expertise who are looking to make a strategic impact on cutting-edge healthcare projects in gene therapy, lab informatics, and clinical systems.
Key Responsibilities:
Drive R&D IT system implementation by applying expert-level business analysis, SDLC knowledge, and testing strategies
Lead the transition from traditional CSV to Computer Software Assurance (CSA) approaches for software and non-instrument systems
Oversee lab informatics system implementation, integration, and validation activities
Apply strategic planning and critical thinking to develop tailored validation methodologies
Troubleshoot issues in regulated R&D environments and propose effective, compliant solutions
Support and validate key R&D platforms such as Veeva, EDC, Oracle Fusion, Shiny apps, Tracelink, SAS, and AMS systems
Provide subject matter expertise on Veeva configuration, including security profiles, reference lookups, DACs, and connector integrations
What We're Looking For:
Minimum 10 years of relevant industry experience in computer system validation
Strong experience validating R&D systems such as:
Veeva (Quality, RIM, CTMS, Safety)
LabVantage (preferred)
EDC platforms, Shiny apps, Tracelink, Pinnacle SAS, Oracle Fusion, GLAMS/AMS
Demonstrated experience in gene therapy environments
Strong SDLC, system configuration, and testing strategy knowledge
Business analysis skills with the ability to translate user needs into functional specifications
Proficiency with Veeva connector projects and relevant validation practices
Strong problem-solving and communication skills
Ability to work in fast-paced, regulated, and collaborative environments
Key Traits for Success:
Strategic thinker with strong analytical skills
Effective communicator across technical and non-technical teams
Detail-oriented and organized in managing complex validation workflows
Comfortable navigating ambiguity in evolving R&D environments
Passionate about innovation, compliance, and continuous improvement
Why Join Us?
High-growth organization with people-focused culture
Competitive salary and performance-based bonus potential
Full suite of healthcare benefits: medical, dental, vision
Company-paid life, short-term, and long-term disability insurance
401(k) plan with employer matching
Health Savings Account (HSA), FSA, and commuter benefits
Paid time off, holidays, and flexible sick leave
Tuition reimbursement and continuing education support
Paid parental leave and bereavement policies
Employee referral and recognition programs
Frequent team-building and social events
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.Â
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.Â
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.