CSV Engineer

Location: Visp, Switzerland

Role Type: Contract/Full-Time

We are seeking a skilled and motivated CSV (Computer System Validation) Engineer to support assigned projects in Visp. The successful candidate will work closely with cross-functional teams, ensuring the compliance and execution of CSV activities throughout the project lifecycle.

Key Responsibilities:

• Develop and manage CSV documents according to company SOPs.
• Execute CSV tests and ensure adherence to project timelines in collaboration with Project Managers and CQV Leads.
• Collaborate with Process Engineers, Automation Teams, and QA to drive a consistent CQV/CSV approach.
• Act as the primary CSV point of contact for assigned systems until handover to the operational team.
• Serve as a subject matter expert (SME) on CQV/CSV standards and practices.
• Participate in system impact assessments as the CSV SME.
• Define appropriate design solutions with EMR and package unit vendors for vertical integration within the project environment.
• Oversee the review, approval, and management of CSV documentation, including FAT and SAT participation.
• Develop and execute test protocols while ensuring quality and regulatory compliance.
• Monitor project compliance with CQV guidelines and identify potential gaps for resolution.
• Represent the CSV function in inspections and audits, as required.

Candidate Profile:

Qualifications:

• Technical degree (Bachelor’s level) in Engineering or Applied Sciences; postgraduate qualifications preferred.
• Minimum of 5+ years’ experience in Commissioning, Qualification, and Validation (CQV), with a focus on CSV.

Experience & Skills:

• Significant experience in automation and vertical integration, with expertise in data management under validated computer systems.
• Strong background in managing complex pharmaceutical projects, ideally within biologics (mammalian, CGT) or chemical manufacturing technologies.
• Extensive experience in the regulated pharmaceutical industry or engineering environments, with proven planning and management of CQV activities.
• Expertise in ISPE GAMP5 and ASTM guidelines, with experience managing large and complex projects.
• Comprehensive knowledge of EMA/FDA-regulated environments, as well as ICH, PIC/S, EU, and US regulatory requirements.
• Experience in people management, including coaching and development of internal and external team members.
• Strong collaboration and influencing skills in a matrix environment.
• Excellent analytical, prioritisation, and decision-making skills.
• Effective oral and written communication skills, with fluency in English and German required (additional languages are an advantage).
• Ability to work independently and as part of a team in a fast-paced environment.
• Willingness and ability to train and support colleagues.

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