Technical Lead
United States
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Job Description
Technical Lead
Others, New Jersey

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.

• 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.

·  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.

 

Key Responsibilities

·  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.

• 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.

·  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.

 

Skill Requirements

Other Requirements
Maximum Salary (US): 
Minimum Salary (US): 
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Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion. 

 

Compensation and Benefits

A candidate’s pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.