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.