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Senior CSV Validation Engineer
Pharma Automation & Digital Systems

We are supporting a strategic modernisation initiative within a highly regulated pharmaceutical manufacturing environment focused on Synthetic Molecule Clinical and Launch Facilities.

Existing Drug Substance Small Molecule production systems are being upgraded to meet evolving operational, digitalisation, and compliance requirements. A key focus is the qualification and validation of manufacturing control systems in line with current GMP, GxP, and CSV standards.

• Lead and author validation-compliant User Requirement Specifications (URS) for automated manufacturing systems
• Develop and review functional specifications aligned with GMP, GxP, and CSV expectations
• Ensure computerised systems and process control platforms are validated to internal quality and regulatory standards
• Define validation roadmaps, project milestones, and execution timelines for CSV activities
• Coordinate and oversee validation deliverables for compliance, documentation quality, and on-time execution
• Collaborate closely with Engineering, Automation, Technical Compliance, and project delivery teams
• Drive preparation, review, and maintenance of complete CSV lifecycle documentation
• Support risk assessments, test strategy definition, protocol management, and traceability reviews
• Act as key interface between technical project teams and quality / compliance stakeholders

• Degree in Automation Engineering, Computer Science, Life Sciences, Pharmaceutical Engineering, or similar
• Minimum 10 years of experience in Computerised System Validation within pharma or biotech
• Proven expertise with DCS, SCADA, Process Control Systems, or comparable automation platforms
• Strong hands-on experience authoring URS, functional specifications, validation plans, and CSV documentation
• In-depth understanding of GMP, GxP, CSV methodologies, data integrity, and validation lifecycle management
• Experience with electronic validation and documentation management systems (eVAL or equivalent)
• Strong project coordination with a structured and compliance-oriented mindset
• Fluent English, written and spoken

• Experience leading digital transformation or automation upgrade projects in GMP environments
• Background in facility modernisation, brownfield projects, or pharmaceutical launch facilities
• Familiarity with Small Molecule / Drug Substance manufacturing
• Experience in multidisciplinary and international project organisations

• Competitive consulting rate commensurate with experience
• 12-month contract with extension possibility
• Strategic modernisation project in a top-tier pharma environment
• Direct relationship - simple, transparent process

Send your CV to t@morganu.ch — we will come back to you within 48 hours.

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