Inova Consulting

Inova Consulting offers AI-boosted quality, validation, and engineering services for Life Sciences in simple terms. It leverages in-house AI tools to improve precision and speed across projects for…

AIBiotechConsultingEngineeringLife SciencesPharmaQuality AssuranceValidationinova-sa.ch

Inova Consulting

AIBiotechConsultingEngineeringLife SciencesPharmaQuality AssuranceValidationinova-sa.ch

HQLausanne, CH

Team Size34

Open Jobs14

Total Funding-

Latest FundraiseUnknown

Join the Team

CSV Specialist

On-SiteBasel, Basel, CH

On-Site • Basel, Basel, CH

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Job Title: CSV Specialist – Pharma Industry

Company: Inova (www.inova-sa.ch)

Location: Basel Area, Switzerland

Contract Type: Full-time – On-site

About Inova:

Inova is a Swiss consulting and engineering company providing expert services to the pharmaceutical, biotech, medtech, and chemical industries. We support our clients in ensuring compliance, efficiency, and innovation across regulated environments — including strong expertise in computerized systems validation (CSV), data integrity, and digital quality systems.

Position Overview:

We are currently looking for a CSV Specialist to support computerized systems validation activities on a GMP pharmaceutical site in the Basel area . You will ensure that systems used in manufacturing, quality control, and support functions comply with regulatory expectations and internal procedures.

Key Responsibilities:

Profile Requirements:

Why Join Inova?

Contribute to key CSV projects in a high-standard GMP setting
Collaborate with expert teams in QA, IT, and digital validation
Join a fast-growing consulting team with opportunities for technical development
Enjoy a dynamic and supportive work culture in the life sciences industry

How to Apply:

📩 Send your application to careers@inova-sa.ch

Subject line: CSV Specialist – Basel

Inova is an equal opportunity employer. We welcome applicants from all backgrounds and are committed to creating an inclusive workplace.

Perform validation of GxP computerized systems in accordance with CSV guidelines and data integrity principles

Author and review validation documentation: URS, risk assessments, IQ, OQ, PQ, traceability matrix , etc.

Ensure compliance with Annex 11 , FDA 21 CFR Part 11 , and GAMP 5 guidelines

Collaborate with QA, IT, engineering, and system owners to support validation lifecycle

Support periodic review, change control, deviation handling, and revalidation activities

Participate in audits and inspections related to computer system validation

Contribute to data integrity assessments and remediation plans

Maintain accurate documentation and provide project status updates

Degree in Life Sciences , Computer Science , Engineering , or related field

Experience with CSV in GMP environments (lab, manufacturing, QC, etc.)

Strong understanding of GAMP 5 , Annex 11 , and Part 11

Familiarity with validation of lab systems, manufacturing systems, or QMS tools

Knowledge of data integrity principles and best practices

Proactive, structured, and quality-oriented mindset

Fluent in English ; German is a strong asset