Senior CSV Consultant – Life Sciences Validation Expert

ARM International; Barcelona; On-site; EUR 60,000 - 90,000; Full time

Job summary

ARM International is seeking a Computer System Validation (CSV) Consultant to join its growing life sciences consultancy team. The role focuses on leading CSV activities across pharma, biotech, and medical device projects in a collaborative, international environment.

You will author and review validation plans, URS, risk assessments, IQ/OQ/PQ protocols, and summary reports, while ensuring compliance with GMP, GxP, Annex 11, and 21 CFR Part 11 across multiple client engagements.

Qualifications

• Minimum 5 years' experience in Computer System Validation within pharmaceutical, biotechnology or medical device environments.
• Strong understanding of GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Experience validating systems such as Veeva Vault, TrackWise, SAP, LabWare, LIMS, eQMS platforms.
• Strong stakeholder management and communication skills.

Responsibilities

• Lead and support CSV activities across a range of life sciences clients.
• Author and review validation documentation including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols and summary reports.
• Support validation and qualification activities for GxP-regulated systems and applications.
• Work with cross-functional stakeholders to ensure compliance with GMP, GxP, Annex 11 and 21 CFR Part 11 requirements.
• Participate in system implementations, upgrades and remediation activities.
• Provide expert validation guidance to clients throughout project lifecycles.
• Support audits, inspections and quality initiatives where required.

Skills

Stakeholder management

Communication skills

Tools

Veeva Vault

TrackWise

SAP

LabWare

LIMS

eQMS

Job description

ARM International is seeking a Computer System Validation (CSV) Consultant to join its growing life sciences consultancy team. The role focuses on leading CSV activities across pharma, biotech, and medical device projects in a collaborative, international environment.

You will author and review validation plans, URS, risk assessments, IQ/OQ/PQ protocols, and summary reports, while ensuring compliance with GMP, GxP, Annex 11, and 21 CFR Part 11 across multiple client engagements.