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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