CSV Expert (m/f)

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment targeting perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.

Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium

Mithra est à la recherche d’un(e) Expert en Validation des système informatisés/automatisés pour le Mithra CDMO, sa plateforme R&D et production basée à Flémalle.

• Participate to projects follow-up meetings and schedule appropriately CSV activities related to new equipment/systems to be qualified/validated
• Schedule appropriately CSV activities related to periodic evaluations of already qualified/validated systems
• Is involved and participates early in projects launching and gives input regarding pre-requisites needed for CSV activities
• Write and/or review of the qualification / validation documents related to CSV activities (URS, risk analyses, protocols, reports, …) for production and QC equipment
• Execute CSV testing on production and QC equipment
• When appropriate, manage, write, investigate and follow up of deviations related to CSV topics.
• When appropriate, write SOP or work instructions related to CSV activities.
• When appropriate, gives input related to CSV status of equipment/systems during updates of the DVP’s of the different production and QC entities
• Act as an SME during authorities and customers inspections/audits for CSV topics
• Be able to find the correct balance between quality, output, safety and cost.
• Follow training as needed to fulfill function requirements
• Actively participate in continuous improvement of plant activities

• Minimum 5 years as Process control/automation Computer System validation expert

  Knowledge:

  • Project managment
  • Periodic Reviex
  • Change managment
  • CSV Assessment
  • GMP
  • Eudralex Volume Annex 11 et 15
  • 21 CFR Part 210-211
  • GAMP5
  • 21 CFR Part 11
  • Automation (PLC, SCADA, instrumentation)

Varied and motivating responsibilities within a fast growing company.
An attractive salary package in line with your experience.

Please follow this link to submit your resume and application letter : https://careers-mithra.icims.com/jobs/1104/csv-expert—computer-system-validation/job?mode=view