GMP CSV Consultant - LIMS Upgrade (Remote)

Pioneer GMP Consulting; Poland; Remote; PLN 411,000 - 598,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Life insurance

Paid holidays

Flexible PTO

Leadership access

Job summary

Pioneer GMP Consulting seeks an experienced CSV Consultant for a client engagement upgrading a GMP-regulated LIMS. The role involves validation planning, documentation development, testing, and implementation support, with remote work primarily and limited onsite travel to Louisville, CO.

You will collaborate with Laboratory, Quality, IT, and vendors to drive deliverables, manage risk-based validation, and ensure traceability and inspection-ready documentation throughout the lifecycle.

Qualifications

• At least five years of computer-system validation experience in GMP environments.
• Direct experience validating LIMS implementations, upgrades, or significant system changes.
• Experience developing and executing risk-based computer-system validation documentation.
• Experience supporting validation plans, requirements, risk assessments, specifications, test scripts, traceability matrices, discrepancy management, and validation-summary reports.
• Ability to travel to Louisville, Colorado for limited onsite activities.
• Bachelor’s degree in information systems, computer science, engineering, life sciences, or related field.

Responsibilities

• Support the validation of a GMP-regulated LIMS upgrade.
• Review the system’s use, configuration, validation status, and lifecycle documentation.
• Develop or update validation plans and lifecycle documentation.
• Facilitate risk assessments and traceability activities.
• Develop, review, and execute validation test scripts.
• Support testing, validation gaps, and discrepancy resolution.
• Prepare validation-summary reports and final release artifacts.
• Collaborate with Laboratory, Quality, IT, and vendors to move deliverables forward.
• Travel to client site in Louisville, CO as needed.

Skills

Client communication

GxP mindset

Documentation writing

Risk-based thinking

Independent delivery

Problem solving

Time management

Education

Bachelor’s degree in information systems, computer science, engineering, life sciences, or related field

Tools

LIMS

GAMP 5

FDA 21 CFR Part 11

Job description

Pioneer GMP Consulting seeks an experienced CSV Consultant for a client engagement upgrading a GMP-regulated LIMS. The role involves validation planning, documentation development, testing, and implementation support, with remote work primarily and limited onsite travel to Louisville, CO.

You will collaborate with Laboratory, Quality, IT, and vendors to drive deliverables, manage risk-based validation, and ensure traceability and inspection-ready documentation throughout the lifecycle.