CSV Engineer (m/f/d) Process Manufacturing

Location: Melsungen, Hessen, Germany; hybrid working model

Company

hirify.global develops healthcare solutions and works across hospital care, digital process development, and regulated manufacturing.

What you will do

• Plan, execute, and document computerized systems validation and qualification activities throughout system and project lifecycles.
• Develop qualification and validation plans, including DQ, IQ, OQ, PQ, PV, risk assessments, and testing guidelines.
• Support qualification environments, site rollouts, data integrity activities, and collaboration with local teams.
• Coordinate validation activities, analyze measurement results and raw data, and prepare validation reports.
• Maintain validation documentation and archives, initiate corrective actions, and report significant deviations and project progress.
• Work with project teams, the Quality Unit, IT, Engineering, and other stakeholders to ensure regulatory and internal compliance.

Requirements

• Completed vocational training, dual-study program, or university degree in a scientific discipline, pharmaceutical engineering, process engineering, or a comparable field.
• Several years of professional experience in Computerized Systems Validation, preferably in the pharmaceutical industry.
• Good written and spoken English and solid IT skills, including MS Office.
• Strong teamwork, communication, professional presence, and a structured, independent, solution-oriented working style.
• Willingness to travel and flexibility.

Culture & Benefits

• Flexible working arrangements, including flextime and home office options.
• Employee networks and employee discounts.
• Company pension scheme.
• Mobility benefits, including the hirify.global Job Ticket and Job Bike.
• Work-life integration offerings, including holiday childcare programs.