Computer System Validation (CSV) Lead 18582

Veritaz AB; Sweden; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Veritaz AB in Sweden is seeking an experienced Validation Lead to drive the validation strategy across projects and ensure compliance with GMP and GxP. You will lead CSV activities and coordinate IQ/OQ with cross-functional teams, delivering robust validation documentation and risk assessments.

The ideal candidate has extensive pharma validation experience, strong leadership, and deep knowledge of DeltaV or similar automation platforms, with a track record of delivering projects on time and

Qualifications

• Several years of validation experience within the pharmaceutical industry.
• Strong knowledge of GMP and GxP regulatory requirements.
• Extensive experience with Computerized System Validation (CSV).
• Experience validating computerized systems, manufacturing processes, and technical equipment.
• Practical experience with DeltaV or similar automation platforms in regulated environments.
• Experience developing validation strategies and verification approaches.
• Experience conducting risk assessments and qualification planning.
• Experience with traceability matrices and requirements management.
• Experience handling deviations, CAPA, and validation documentation.
• Strong leadership, coordination, and stakeholder management skills.
• Excellent communication and technical documentation skills.

Responsibilities

• Define and lead the overall validation strategy for the project.
• Develop verification and qualification approaches for technical systems and equipment.
• Lead validation activities across project phases.
• Perform and coordinate risk assessments related to validation.
• Ensure full compliance with GMP and GxP regulations.
• Lead Computerized System Validation (CSV) activities.
• Validate computerized systems, manufacturing processes, and technical equipment.
• Support validation of DeltaV or similar automation platforms.
• Develop and maintain traceability matrices.
• Coordinate qualification activities including IQ, OQ, and related verification processes.
• Manage validation documentation and compliance deliverables.
• Lead deviation investigations, CAPA activities, and corrective actions.
• Collaborate with automation, process, commissioning, engineering, and quality teams.
• Coordinate validation activities across multiple stakeholders.
• Ensure successful delivery of validation objectives within project timelines.

Skills

Validation

GMP/GxP

CSV

DeltaV

Leadership

Regulatory compliance

Risk assessment

Traceability

Documentation

Stakeholder mgmt

Tools

DeltaV

IQ/OQ

Validation software

Job description

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in ensuring the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.

Assignment Description

We are looking for an experienced Validation Lead

What You Will Work On

• Define and lead the overall validation strategy for the project
• Develop verification and qualification approaches for technical systems and equipment
• Lead validation activities across project phases
• Perform and coordinate risk assessments related to validation
• Ensure full compliance with GMP and GxP regulations
• Lead Computerized System Validation (CSV) activities
• Validate computerized systems, manufacturing processes, and technical equipment
• Support validation of DeltaV or similar automation platforms
• Develop and maintain traceability matrices
• Coordinate qualification activities including IQ, OQ, and related verification processes
• Manage validation documentation and compliance deliverables
• Lead deviation investigations, CAPA activities, and corrective actions
• Collaborate with automation, process, commissioning, engineering, and quality teams
• Coordinate validation activities across multiple stakeholders
• Ensure successful delivery of validation objectives within project timelines

What You Bring

• Several years of validation experience within the pharmaceutical industry
• Strong knowledge of GMP and GxP regulatory requirements
• Extensive experience with Computerized System Validation (CSV)
• Experience validating computerized systems, manufacturing processes, and technical equipment
• Practical experience with DeltaV or similar automation platforms in regulated environments
• Experience developing validation strategies and verification approachesExperience conducting risk assessments and qualification planning
• Experience with traceability matrices and requirements management
• Experience handling deviations, CAPA, and validation documentation
• Strong leadership, coordination, and stakeholder management skills
• Excellent communication and technical documentation skills