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# Senior Technical Lead

- **Company:** HCL America, Inc.
- **Location:** United States
- **Experience:** Expert
- **Salary:** $95,000.0 - $151,000.0
- **Contract:** Permanent contract
- **Skills:** Software Applications, Data Integrity, Systems Development Life Cycle, System Testing, Iq/oq/pq, Veeva, GXP
- **Published:** October 7, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=a311a7a27b043348

## About the Role

* Strong experience in Computer System Validation (CSV) within GMP-regulated pharmaceutical/manufacturing environments.
 * Knowledge of Validation Lifecycle, CSA, SDLC, Qualification (IQ/OQ/PQ), Change Control, CAPA, and Risk Management.
 * Experience reviewing and approving validation documentation and compliance deliverables.
 * Familiarity with GxP regulations, Data Integrity, FDA, EMA, and industry compliance requirements.
 * Exposure to one or more manufacturing automation platforms including:
 * DeltaV DCS
 * PLC systems (Rockwell and/or Siemens)
 * Process Historians
 * Laboratory Automation Systems

 * Experience with validation, qualification, change control, risk assessments, and lifecycle compliance activities associated with manufacturing and laboratory computerized systems.
 * Understanding of GxP, Data Integrity, CSV/CSA, and SDLC requirements for manufacturing automation platforms

## Description

Primary: CSV (Computer System Validation) Compliance
Secondary: SDLC / CSA / Validation Governance / Quality Compliance
Hands-on experience supporting validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment.
Familiar with Kneat,SNOW,Veeva Systems.

 * Provide CSV compliance support for Capital and Strategic Projects to ensure continuity of compliance oversight and project delivery.
 * Develop, review, and approve validation lifecycle deliverables in accordance with GxP requirements, internal SOPs, and regulatory expectations.
 * Provide compliance guidance to project teams on SDLC, CSA (Computer Software Assurance), qualification, risk-based validation, and change control processes.