CSV Lead

JobDiva, Inc.; Cambridge (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

JobDiva, Inc. in Cambridge, MA seeks an experienced Computer System Validation (CSV) Lead to oversee validation activities for GxP computerized systems.

You will manage end-to-end CSV lifecycle, develop and review validation deliverables, and ensure systems meet regulatory requirements. The role requires 8–12+ years in CSV within pharma/biotech, strong knowledge of 21 CFR Part 11, Annex 11 and GAMP 5, and collaboration with IT, QA, and manufacturing.

Qualifications

• 8–12+ years of Computer System Validation experience in regulated environments.
• Strong understanding of GxP regulations and validation standards (21 CFR Part 11, Annex 11, GAMP 5).
• Experience validating enterprise systems such as LIMS, MES, ERP (SAP), QMS, DMS and related software.

Responsibilities

• Lead end-to-end CSV activities for GxP systems.
• Develop and review Validation Plans, Protocols, Risk Assessments and TRMs.
• Execute IQ, OQ, PQ activities and maintain lifecycle documentation.
• Coordinate with IT, QA, Engineering, Manufacturing and Business teams.
• Support internal and regulatory audits and inspections.
• Mentor junior CSV engineers and ensure SOP compliance.

Skills

CSV lifecycle management

Regulatory compliance

Risk assessments

Cross-functional collaboration

Mentoring

Education

Bachelor's or Master's degree in related field

Tools

LIMS

MES

ERP (SAP)

QMS

DMS

EBR

SCADA

PLC/HMI

Job description

Job Description:

We are seeking an experienced Computer System Validation (CSV) Lead to oversee validation activities for computerized systems used in regulated GxP environments. The ideal candidate will have extensive experience in CSV lifecycle management, FDA and global regulatory compliance, validation documentation, risk assessments, and cross-functional collaboration to ensure validated systems meet business and regulatory requirements.

Responsibilities:

• Lead end-to-end Computer System Validation (CSV) activities for GxP computerized systems.
• Develop and review Validation Plans, Validation Protocols, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
• Execute and oversee IQ, OQ, and PQ activities.
• Ensure compliance with 21 CFR Part 11, Annex 11, GAMP 5, FDA, EMA, and other global regulatory requirements.
• Review User Requirements Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
• Perform risk assessments using GAMP 5 methodology.
• Manage deviations, CAPAs, change controls, and periodic reviews.
• Support software implementation, upgrades, migrations, and decommissioning projects.
• Coordinate validation activities with IT, Quality Assurance, Engineering, Manufacturing, and Business teams.
• Support internal audits, customer audits, and regulatory inspections.
• Mentor junior CSV engineers and provide technical guidance.
• Maintain validation lifecycle documentation according to company SOPs.

Requirements:

• Bachelor's or Master's degree in Computer Science, Information Technology, Biotechnology, Pharmacy, Engineering, Life Sciences, or a related field.
• 8–12+ years of Computer System Validation experience in the pharmaceutical, biotechnology, medical device, or life sciences industry.
• Strong understanding of GxP regulations and computerized system validation.
• Experience validating enterprise systems such as:
  • LIMS.
  • MES.
  • ERP (SAP).
  • Laboratory Systems.
  • SCADA.
  • PLC/HMI.
  • Manufacturing Execution Systems.
  • Electronic Batch Records (EBR).
  • Quality Management Systems (QMS).
  • Document Management Systems (DMS).