CSV Specialist

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

Senior CSV Engineer, Pharmaceutical IT Systems

Location: Basel Area, Switzerland

Contract: Full-time | On-site

Start Date: ASAP

Experience: 8–20 years

Language: English only

About Inova

Inova is a Swiss consulting and engineering firm supporting life sciences industries through high-value expertise in engineering, quality, compliance, and digital transformation.

We help pharmaceutical and biotech companies implement, validate, and maintain critical systems in regulated GMP environments.

Position Overview

We are seeking an experienced Senior CSV Engineer to lead validation activities for GxP-regulated IT systems at a pharmaceutical site in Basel.

This is a hands‑on technical role requiring strong expertise in Computerized Systems Validation, IT architectures, and GMP compliance.

You will independently drive validation activities, challenge technical solutions, and collaborate with IT, QA, and business stakeholders throughout the system lifecycle.

Key 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.

Profile Requirements

• Degree in IT, Computer Science, Engineering, or a related field.


• 8–20 years of experience, including 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.


• Cloud/SaaS validation, IT migrations, and infrastructure qualification are strong assets.


• Autonomous, pragmatic, technically sharp, and comfortable engaging with IT and QA stakeholders.


• Fluent English mandatory.


• Available at short notice for an on‑site assignment in Basel.

Why Join Inova?

• Contribute to critical pharmaceutical IT validation projects.


• Work at the intersection of IT, digital manufacturing, and GMP compliance.


• Join an experienced team that values technical excellence, autonomy, and collaboration.

Inova is an equal opportunity employer.