Lead CSV Engineer – Computer System Validation & Compliance

QvalFocus Inc.; New Jersey; On-site; USD 140,000 - 210,000; Full time

Job summary

QvalFocus Inc. in New Jersey seeks a Lead CSV Engineer to lead Computer System Validation for capital and strategic projects in a GMP-regulated setting. You will guide CSV/CSA practices, review validation deliverables, and ensure systems meet regulatory requirements.

The role requires deep knowledge of SDLC, risk-based validation, and automation compliance. You will collaborate with Quality, Engineering, Automation, and Project Delivery teams across multiple sites to ensure on-time delivery.

Qualifications

• Bachelor's degree in engineering, computer science, life sciences, or related field.
• 7+ years of CSV experience in GMP-regulated environments.
• Strong knowledge of CSV, CSA, SDLC and validation compliance for manufacturing, QA, and enterprise systems.
• Familiarity with GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and GMP requirements.
• Experience authoring, reviewing, and approving validation docs (requirements, risk assessments, test protocols, summaries).
• Knowledge of risk-based validation, system qualification, and lifecycle management.
• Experience supporting capital projects, system implementations, upgrades, and validation activities.
• Familiarity with change control, deviation management, and quality processes.

Responsibilities

• Lead CSV compliance activities for capital projects across multiple sites.
• Develop, review, and approve CSV lifecycle documentation (QAPs, risk assessments, requirements, test protocols, summary reports).
• Provide technical guidance on SDLC, CSA, risk-based validation, and computerized system compliance.
• Review SDLC documentation as technical representative; ensure regulatory alignment.
• Support validation planning, execution, and compliance for GMP systems in manufacturing, labs, quality, and enterprise ops.
• Collaborate with project teams to assess changes, risks, and support change controls and deviations.
• Participate in governance, technical reviews and meetings to address validation requirements.
• Maintain CSV trackers, compliance metrics, validation schedules, and status reports.
• Identify compliance gaps and risks and communicate to Global CSV Compliance Lead.
• Support development and improvement of CSV procedures, SOPs, and practices.
• Coordinate with Quality, IT, Engineering, Automation, and project stakeholders to complete activities on schedule.

Skills

CSV, CSA, SDLC

GAMP 5, FDA 21 CFR Part 11

Regulatory compliance

Independent multi-project oversight

Documentation & communication

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Job description

Lead CSV Engineer Computer System Validation & ComplianceJob Summary

We are looking for an experienced

Summary

Lead CSV Engineer Computer System Validation & ComplianceJob Summary

We are looking for an experienced Lead CSV Engineer to manage Computer System Validation (CSV) compliance activities for capital and strategic projects within a regulated pharmaceutical or biotechnology environment.
The role will focus on providing technical compliance guidance, reviewing and approving validation deliverables, supporting risk-based validation approaches, and ensuring computerized systems meet GMP and regulatory requirements.
The ideal candidate should have strong experience in CSV, Computer Software Assurance (CSA), SDLC, and automation compliance, with the ability to work independently across multiple projects and collaborate with Quality, Engineering, Automation, and Project Delivery teams.

Key Responsibilities

• Lead and coordinate CSV compliance activities for capital projects and strategic initiatives across multiple sites.
• Develop, review, and approve CSV lifecycle documentation, including Quality Assurance Plans (QAPs), risk assessments, requirements specifications, test protocols, and validation summary reports.
• Provide technical guidance on SDLC, CSA, risk-based validation, qualification, and computerized system compliance.
• Review and approve SDLC documentation as the designated technical representative, ensuring alignment with internal procedures and regulatory expectations.
• Support validation planning, execution, and compliance oversight for GMP computerized systems used in manufacturing, laboratories, quality, and enterprise operations.
• Work with project teams to assess system changes, evaluate compliance risks, and support change controls and deviation investigations.
• Participate in project meetings, technical reviews, and governance discussions to address validation and compliance requirements.
• Maintain CSV project trackers, compliance metrics, validation schedules, and status reports.
• Identify potential compliance gaps, documentation issues, and project risks, and communicate them to the Global CSV Compliance Lead.
• Support the development, implementation, and improvement of CSV procedures, SOPs, and compliance practices.
• Coordinate with Quality, IT, Engineering, Automation, and project stakeholders to ensure validation activities are completed on schedule.
• Provide guidance to project teams on regulatory expectations, documentation standards, and appropriate validation approaches.
  

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
• 7+ years of experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other GMP-regulated environments.
• Strong experience with CSV, CSA, SDLC, and validation compliance for manufacturing, laboratory, quality, and enterprise systems.
• Good understanding of GAMP 5, FDA 21 CFR Part 11, EU GMP Annex 11, and applicable GMP requirements.
• Experience authoring, reviewing, and approving validation lifecycle documentation, including requirements, risk assessments, test protocols, and summary reports.
• Practical knowledge of risk-based validation approaches, system qualification, and computerized system lifecycle management.
• Experience supporting capital projects, system implementations, upgrades, and validation activities.
• Familiarity with change control, deviation management, compliance risk assessments, and quality processes.
• Ability to independently manage CSV compliance responsibilities across multiple projects and sites.
• Strong communication, documentation, stakeholder coordination, and problem-solving skills.
  

Preferred Qualifications

• Experience supporting automation and manufacturing systems such as PLC, SCADA, DCS, MES, or Historians.
• Exposure to laboratory and quality systems such as LIMS, CDS, eQMS, or other GMP computerized applications.
• Experience providing CSV compliance oversight for engineering and automation projects.
• Familiarity with regulatory inspection readiness, audit support, and SOP improvements.
• Experience working with global project teams and cross-functional stakeholders.