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

Job Summary

Primary: CSV (Computer System Validation) Compliance

Secondary: SDLC / CSA / Validation Governance / Quality Compliance

  • Lead CSV compliance activities for capital and strategic projects.
  • Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11.
  • Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches.
  • Participate in project meetings and CSV compliance reviews.
  • Assist with project change controls, and CSV compliance-related risk assessments.
  • Maintain project CSV compliance trackers, metrics, and reporting.
  • Approval of SDLC documents as technical unit
  • Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.
  • Strong knowledge of:
  • GAMP 5
  • FDA 21 CFR Part 11
  • EU GMP Annex 11
  • Risk-based validation and CSA principles
  • Software Development Lifecycle (SDLC)
  • Change Management and Deviation processes
  • Experience supporting capital projects and GMP computerized systems.
  • Strong stakeholder management and communication skills.
  • Ability to work independently across multiple projects and sites.
  • Role based in Rahway
  • Candidates will need to be legally authorised to live and work in the United States and be willing to commute to site approximately three days per week

Key Responsibilities

Primary: CSV (Computer System Validation) Compliance

Secondary: SDLC / CSA / Validation Governance / Quality Compliance

  • Lead CSV compliance activities for capital and strategic projects.
  • Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11.
  • Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches.
  • Participate in project meetings and CSV compliance reviews.
  • Assist with project change controls, and CSV compliance-related risk assessments.
  • Maintain project CSV compliance trackers, metrics, and reporting.
  • Approval of SDLC documents as technical unit
  • Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.
  • Strong knowledge of:
  • GAMP 5
  • FDA 21 CFR Part 11
  • EU GMP Annex 11
  • Risk-based validation and CSA principles
  • Software Development Lifecycle (SDLC)
  • Change Management and Deviation processes
  • Experience supporting capital projects and GMP computerized systems.
  • Strong stakeholder management and communication skills.
  • Ability to work independently across multiple projects and sites.
  • Role based in Rahway
  • Candidates will need to be legally authorised to live and work in the United States and be willing to commute to site approximately three days per week

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.