Senior CSV Engineer: GMP IT Validation Lead in Basel

Inova Consulting; Basel; On-site; CHF 140,000 - 230,000; Full time

Job summary

Inova is seeking a Senior CSV Engineer to lead validation activities for GxP-regulated IT systems at a pharmaceutical site in Basel. This hands-on role requires deep expertise in Computerized Systems Validation and GMP compliance, with collaboration across IT, QA, and business stakeholders throughout the system lifecycle.

You will independently drive validation deliverables, challenge technical solutions, and ensure ongoing validated state of systems such as LIMS, MES, ERP, and eQMS, while

Qualifications

• Degree in IT, Computer Science, Engineering, or a related field.
• 8–20 years of experience with substantial CSV expertise in pharmaceutical or biotech environments.
• Proven experience validating GxP IT systems, beyond equipment qualification.
• Strong technical understanding of IT infrastructure, applications, databases, and system interfaces.
• Excellent knowledge of GAMP 5, Annex 11, Part 11, and data integrity.
• Experience with LIMS, MES, ERP, eQMS, or similar enterprise applications.

Responsibilities

• Lead CSV activities for GxP IT applications and infrastructure.
• Develop and execute validation deliverables: URS, risk assessments, validation plans, IQ/OQ/PQ, traceability matrices, and reports.
• Validate pharmaceutical IT systems, including LIMS, MES, ERP, eQMS, and EDMS.
• Assess IT architectures, interfaces, configurations, data flows, and system changes.
• Ensure compliance with GAMP 5, Annex 11, 21 CFR Part 11, and ALCOA+.
• Manage change controls, deviations, periodic reviews, and revalidation.
• Support system upgrades, migrations, integrations, and audit readiness.
• Maintain the validated state of computerized systems throughout their lifecycle.

Skills

CSV validation

GxP IT systems

GAMP 5

Audit readiness

Stakeholder engagement

Education

Bachelor's degree in IT/CS/Engineering

Tools

LIMS

MES

ERP

eQMS

Job description

Inova is seeking a Senior CSV Engineer to lead validation activities for GxP-regulated IT systems at a pharmaceutical site in Basel. This hands-on role requires deep expertise in Computerized Systems Validation and GMP compliance, with collaboration across IT, QA, and business stakeholders throughout the system lifecycle.

You will independently drive validation deliverables, challenge technical solutions, and ensure ongoing validated state of systems such as LIMS, MES, ERP, and eQMS, while