Automation & Validation Engineer (GMP / CSV)

Role Overview

We are looking for an experienced Automation & Validation Engineer (GMP / CSV) to support a pharma project in the Basel region.

This is a consulting role in a highly digital GMP environment, focused on validation of automated systems and data-driven platforms, including industrial data historian systems.

The role sits at the intersection of CSV, automation, and digital pharma infrastructure.

Key Responsibilities

• Lead and execute Computer System Validation (CSV) activities for automated systems
• Manage validation lifecycle activities (URS, FS/DS, IQ, OQ, PQ)
• Ensure compliance with GMP / GxP and data integrity requirements
• Validate and support automation + data systems, including interfaces and integrations
• Work with OSIsoft PI / AVEVA PI Data Historian and related digital infrastructure
• Collaborate with Automation, IT, and QA teams in a complex system landscape
• Manage deviations, CAPAs, and change control processes
• Support audits and regulatory inspections

Your Profile

• Strong experience in CSV within GMP-regulated environments (typically 5+ years preferred)
• Hands-on experience with automation systems validation
• Familiarity with OSI PI Data Historian or similar industrial data platforms
• Solid understanding of GMP / GxP and data integrity principles
• Experience in data-driven or highly digital pharma environments
• Ability to work independently in a consulting/project setting
• English proficiency required

Nice to Have

• Experience with MES, SCADA, DCS, or DeltaV systems
• Pharma / biotech manufacturing background
• Experience in consulting or multi-site validation projects
• Exposure to data integrity frameworks and digital QA initiatives

Digital & Innovation Focus (Important)

This project operates in a highly digital environment with increasing focus on:

• data-driven validation approaches
• automation of validation activities where possible
• improving efficiency of CSV processes

We are particularly interested in candidates who are open to exploring: how AI or advanced analytics could support validation, documentation, or data integrity in regulated environments

(This is not a research role, but an opportunity to contribute to modernization efforts.)

Offer

• Competitive consulting rate (equivalent CHF 130k–160k annual gross depending on experience)
• Exposure to a modern digital pharma environment in Basel area
• Strong potential for project extension
• Collaboration with experienced automation, IT, and QA teams