About Us:
CodeForce 360 is a trusted global IT talent partner helping Fortune 500 companies, system integrators, and enterprise organizations build high-performing technology teams. With over 16 years of industry expertise, we combine speed, precision, and market intelligence to deliver exceptional talent across today's most in-demand technologies.
About the Job- We are looking for an experienced Senior Technical Lead (CSV Analyst) to join one of our enterprise client engagements. The ideal candidate should have strong expertise in CSV, CSA & SDLC, GAMP 5, FDA 21 along with experience working in fast-paced enterprise environments.
Key Must-Have Skills
- Computer System Validation (CSV): Leading validation and compliance activities for GMP systems.
- Manufacturing Automation Systems: Experience with at least one of the following:
- DeltaV
- PI Historian
- PLC
- Laboratory Automation Systems
- Regulatory Compliance: GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11.
- CSA & SDLC: Computer Software Assurance, Software Development Lifecycle, risk-based validation.
- Validation Documentation: Develop, review, and approve validation lifecycle and SDLC documents.
- Quality & Change Management: Change controls, deviations, risk assessments, and compliance tracking.
- GMP Environment: Experience supporting capital projects and computerized systems in pharmaceutical or biotechnology settings.
Key Responsibilities
- Lead CSV compliance for capital and strategic projects.
- Review and approve validation deliverables and SDLC documentation.
- Guide project teams on CSA, qualification, and validation approaches.
- Support compliance reviews, change controls, and risk assessments.
- Maintain compliance trackers, metrics, and reports.
How To Apply
Job ID: JPC – 239073
Contact:
Name: Srinivas Kanneboina
Email:
Phone:
CodeForce 360 proudly provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by applicable federal, state, or local laws.
