Senior Technical Lead
HCLTech
Senior Technical Lead
About this role
Job Summary
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.
• 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.
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:
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DeltaV DCS
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PLC systems (Rockwell and/or Siemens)
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Process Historians
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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
Key Responsibilities
Skill Requirements
Other Requirements
Frequently Asked Questions
Is the salary disclosed for the Senior Technical Lead position at HCLTech?
The salary for this Senior Technical Lead role at HCLTech is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Technical Lead position at HCLTech located?
This Senior Technical Lead role at HCLTech is based in Others, United States. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
How do I apply for the Senior Technical Lead position at HCLTech?
Click the "Apply Now" button on this page. You will be redirected to HCLTech's official application portal hosted on successfactors where you can submit your application directly.
When was the Senior Technical Lead job at HCLTech posted?
This Senior Technical Lead position at HCLTech was posted on Oct 6, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Technical Lead
HCLTech
You'll be redirected to HCLTech's official application page on successfactors.