CSV Engineer Biologics 80-100% (m/f/d)

Location: CH - Visp, Switzerland; primarily site-based

Company

hirify.global manufactures medicines across a globally connected network of sites and applies its values of collaboration, accountability, excellence, passion, and integrity.

What you will do

• Prepare commissioning and validation documents for new computerized systems and supervise CSV activities for conversion, expansion, and construction projects.
• Provide system lifecycle support for process engineering equipment, facilities, and MES.
• Supervise deviations, GEP and GMP changes, and CAPAs in accordance with approved protocols.
• Coordinate CSV execution with internal groups, external service providers, and suppliers.
• Present CSV documentation during audits and inspections, and schedule and report validation activities.
• Align the CSV strategy with QA CSV for the Biologics scope and improve CSV documentation and procedures.

Requirements

• Bachelor’s, Master’s, Diploma from a technical school, or equivalent experience in a technical field.
• Significant experience with Computerized System Validation in a regulated environment.
• Good knowledge of Microsoft Office and Delta-V.
• Proficient English required for effective collaboration.
• Ability to work primarily on site in Visp.

Nice to have

• Knowledge of KNEAT, COMOS, DMS, TrackWise, or SAP.
• German language skills.

Culture & Benefits

• Agile career opportunities and a dynamic working culture.
• Inclusive and ethical workplace.
• Performance-oriented compensation programs.
• Competitive salary with lifestyle, family, and leisure benefits.
• Relocation assistance for eligible candidates and their families.