Remote CSV Lead for GxP Validation

Jobgether; Netherlands; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Freelance / contract engagement

Full-time allocation ~40 hours/week

Start Sep 2026

Job summary

Jobgether is seeking a CSV Lead based in the Netherlands to oversee validation for capital projects involving computerized manufacturing and laboratory systems. You will lead CSV activities across the full lifecycle, ensure risk-based validation, and provide regulatory guidance in a highly regulated environment.

The role requires hands-on CSV expertise, ability to challenge project teams when needed, and strong stakeholder management across Quality, Engineering, IT/OT, and laboratory functions.

Qualifications

• 5+ years of CSV validation in GMP environments.
• Experience with SDLC, IQ/OQ/PQ, change control, CAPA.
• Knowledge of FDA/EMA expectations for computerized systems.
• Ability to develop, review and approve validation documents.
• Strong cross-functional leadership and communication.

Responsibilities

• Lead CSV and compliance activities for capital projects involving computerized manufacturing and lab systems.
• Plan, execute, review, and approve validation lifecycle activities per GxP and regulatory expectations.
• Provide guidance on CSV/CSA, SDLC, risk-based validation, IQ/OQ/PQ, change control, deviations, and data integrity.
• Conduct risk assessments, define validation strategies, and ensure mitigations are in place.
• Maintain compliance through system implementation, operation, modification, and retirement.
• Collaborate with Quality, Engineering, IT/OT, and laboratory teams across projects.
• Support regulatory inspections and internal audits as required.
• Promote risk-based CSV/CSA practices across manufacturing projects.

Skills

CSV validation

GxP compliance

Risk-based validation

IQ/OQ/PQ

Change control

CAPA

Data integrity

SDLC

Regulatory guidance

Stakeholder leadership

Tools

DeltaV

Rockwell PLCs

Siemens PLCs

Process historians

Laboratory automation

Job description

Jobgether is seeking a CSV Lead based in the Netherlands to oversee validation for capital projects involving computerized manufacturing and laboratory systems. You will lead CSV activities across the full lifecycle, ensure risk-based validation, and provide regulatory guidance in a highly regulated environment.

The role requires hands-on CSV expertise, ability to challenge project teams when needed, and strong stakeholder management across Quality, Engineering, IT/OT, and laboratory functions.