Senior Computer Systems Validation Consultant (GxP)

PharmEng Nordic ApS; Toronto; On-site; CAD 90,000 - 120,000; Full time

Benefits offered by this job

Benefits package

Travel opportunities

Paid holidays

Incentives

Job summary

PharmEng Technology seeks an experienced Computer System Validation Consultant for a project in Toronto, Ontario. You will lead validation activities, configure LabWare LIMS, author essential documents, and ensure GMP compliance.

This role requires strong collaboration with QA and project teams, with opportunities to interact across divisions. The ideal candidate has 3–5 years of CS validation experience in pharma/biotech settings, solid Windows/AD knowledge, and a proven track record in leading

Qualifications

• Bachelor's degree in business/technical area or equivalent.
• 3–5 years experience in Computer Systems Validation in GMP environment.
• Experience authoring IOQ/PQ, and traceability matrices.
• Experience validating reports and data exchange.
• Strong Windows OS knowledge and network understanding.
• Ability to lead a team and coordinate with clients.

Responsibilities

• Prepare validation protocols for GxP critical reports.
• Configure LabWare LIMS in a validated GMP environment.
• Assist in protocol execution, review, and approval.
• Draft and manage documents: URS, FRS, FRA, IQ/OQ, VSR.
• Ensure compliance with regulatory requirements (cGMP/GLP/GAMP).
• Lead project planning and coordination with QA and stakeholders.
• Maintain project documents and communication.

Skills

GxP Validation

LabWare LIMS

QA Collaboration

SOP Review

Education

Bachelor's degree

Tools

LabWare LIMS

Windows OS

Active Directory

Job description

PharmEng Technology seeks an experienced Computer System Validation Consultant for a project in Toronto, Ontario. You will lead validation activities, configure LabWare LIMS, author essential documents, and ensure GMP compliance.

This role requires strong collaboration with QA and project teams, with opportunities to interact across divisions. The ideal candidate has 3–5 years of CS validation experience in pharma/biotech settings, solid Windows/AD knowledge, and a proven track record in leading