CSV Engineer
Ktek Resourcing LLC
Somerville, United States of America
28 days ago
Role details
Contract type
Permanent contract Employment type
Full-time (> 32 hours) Working hours
Regular working hours Languages
English Experience level
SeniorJob location
Somerville, United States of America
Tech stack
JIRA
Data Infrastructure
Systems Development Life Cycle
Test Scripts
Atlassian Tools
GXP
Requirements
- Strong CSV and Quality expertise with ability to independently lead validation activities across the SDLC for GxP systems with minimal supervision. 7-10 years of relevant experience.
- Proven experience with Manufacturing, MES, and Data Platform Applications, including support for global and regional GxP computerized systems.
- Deep knowledge of GxP compliance, FDA/Global regulations, and Inspection Readiness.
- Expertise in validation documentation and deliverables, including review of compliance plans, requirements, design specs, test protocols, test scripts, defects, traceability, reports and system procedures.
- Demonstrated application of risk-based validation and risk management practices.
- Effective leadership and mentoring skills, guiding cross-functional and external teams (Senior and Junior consultants).
- Strong project coordination and stakeholder communication skills, including managing risks, issues, and status reporting.
- Experience in writing documentation (i.e. Compliance Plan, Test Plans, Test Reports, Compliance Summary Reports, and SOPs).
- Knowledge of Agile Tools (e.g., Jira, Xray, qTest, etc.).
- Ability to build collaborative partnerships, work as a team player and support execution of business objectives across teams, including timely escalations to TQ manager.
- Primary Language required: English. Strong verbal and written communication skills.
- Ability to work with dispersed/remote teams and support several projects simultaneously.
- Experience with Acquisitions/Separations/Divestiture efforts is desirable.