CSV Validation Engineer
CSV Validation Engineer
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Job Description
Key Responsibilities:
- Requirements Gathering & Analysis: Collaborate with IT Quality and business stakeholders to elicit analyze translate and document business requirements into functional and technical specifications.
- Documentation: Prepare business requirements functional requirements technical specifications and UAT plans.
- Validation & Testing: Develop user test cases perform user acceptance testing (UAT) and lead validation activities for new implementations and ongoing system maintenance.
- System Implementation & Support: Work with business users to configure systems resolve bugs and implement enhancements.
- SOP Development: Draft and update SOPs templates and operational documentation to align with regulatory standards.
- System Administration: Manage user access provisioning security roles and configuration management for supported systems.
- Stakeholder Engagement: Partner with global teams to ensure timely project delivery meeting regulatory compliance standards (e.g. CFR Part 11).
- Training & Manuals: Develop user manuals and provide training to ensure effective system usage by the business community.
Qualifications:
- Experience:
- Minimum 3 years in IT and/or R&D and Quality operations within the biotech or life sciences industry.
- 5 years of experience implementing solutions for quality clinical operations and regulatory affairs.
- Handson experience with Veeva Vault Benchling or similar platforms is required.
- Knowledge of clinical trial management regulatory operations and Computer Systems Validation (CSV).
- Familiarity with Software Development Life Cycle (SDLC) policies in regulated environments.
- Education:
- Bachelor s degree in Computer Science Pharmaceutical Science Biochemistry Chemistry or related fields is required.
- Master s degree preferred.
- Technical Skills:
- Demonstrated expertise in writing software requirements test specifications and validation protocols.
- Proficiency in managing global/regional projects with crossfunctional teams.
- Certifications (Preferred):
- Training in Clinical Trial Management Regulatory Operations and CFR Part 11.
- CBAP or ISTQB Certifications
Why Join Us
- Work with leading BioPharma clients on cuttingedge IT solutions.
- Opportunity to collaborate with global teams and shape life sciences innovations.
- Flexible remote work environment with support for professional growth.
veeva,validation & testing,stakeholder engagement,validation,system administration,software development life cycle,computer systems validation,cfr,computerized system validation (csv),requirements gathering,benchling,documentation,clinical trial management,life sciences,regulatory operations,sop development,veeva vault,training & manuals,system implementation & support
Employment Type
Full Time
Company Industry
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
