Computer System Validation L2

We are looking for a Senior Computer System Validation Consultant to join an international Life Sciences consultancy supporting global pharmaceutical, biotech, and medical device organisations.

The role involves leading validation activities for ERP and other GxP‑regulated computerised systems, ensuring compliance, quality, and operational excellence across multiple projects.

Key Responsibilities

• Lead validation activities for ERP and other computerized systems (IQ, OQ, PQ) and prepare/review key documentation (VMP, URS, SOPs).

• Ensure alignment with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity requirements.

• Work with systems such as ERP, eDMS, eQMS, LIMS, SCADA, EBR, laboratory platforms, and maintenance systems.

• Assess system compliance and performance, providing recommendations to improve readiness and efficiency.

• Conduct supplier audits and compliance assessments based on global regulatory frameworks.

• Identify risks, propose corrective actions, and support their implementation

• Manage project timelines, documentation, and test execution to ensure on‑time delivery

Requirements

• Bachelor's degree in Chemistry, Engineering, or a related scientific/technical field

• Strong experience in CSV, GxP compliance, and regulated Life Sciences environments

• Ability to manage multiple consulting projects simultaneously

• Fluency in Spanish and English,

• Valid driver's license and willingness to travel to client site

• What We Offer

• Competitive compensation package aligned with experience

• Additional vacation days and flexible salary options

• Hybrid work model 3 days a week in the office, flexible hours, and reduced working hours on Fridays

• International exposure through collaboration with teams across multiple countries

Montreal Associates is acting as an Employment Agency in relation to this vacancy.