Equipment Commissioning & Qualification Engineer - Pharmaceutical Industry M/W/X

Actiris

Geel

À distance

EUR 65 000 - 90 000

Plein temps

Il y a 30 heures
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Résumé du poste

VIQI is seeking a CQV Engineer for a Belgium-based role in the pharmaceutical sector. You will join the Commissioning, Qualification and Validation team to ensure equipment, utilities and facilities meet GMP and quality standards throughout the project lifecycle.

The role focuses on CQV documentation, coordination of commissioning and qualification activities, and collaboration with Engineering, Quality, Production, and Automation. English fluency is required; French/Dutch a plus.

Qualifications

  • Degree in Engineering, Life Sciences, or a related field.
  • Proven experience in CQV within the pharmaceutical or biotech industry.
  • Solid knowledge of GMP requirements and the validation lifecycle (ASTM E2500 / FDA / EMA guidelines).
  • Fluent in English; French and/or Dutch is a plus.
  • Rigorous, autonomous, and comfortable working in a cross-functional environment.
  • Strong communication and documentation skills.

Responsabilités

  • Drafting and reviewing CQV documentation (URS, protocols, reports: IQ, OQ, PQ).
  • Coordinating and/or executing commissioning and qualification activities for equipment, utilities and facilities.
  • Ensuring compliance with GMP requirements and internal quality standards.
  • Managing deviations, investigations and change controls related to CQV activities.
  • Collaborating with Engineering, Quality, Production and Automation teams.
  • Supporting audits and regulatory inspections.

Connaissances

CQV experience
GMP knowledge
Documentation skills
Cross-functional work
English fluency

Formation

Engineering degree
Life Sciences degree

Description du poste

Equipment Commissioning & Qualification Engineer - Pharmaceutical Industry M/W/X

A specialist in the Pharmaceutical and Medical Device industry, VIQI brings together passionate professionals who choose to work exclusively with companies dedicated to patient health.

We are currently looking for a CQV Engineer to join one of our clients, a major player in the pharmaceutical industry, for a mission based in Belgium.

Your Mission :

As part of the Commissioning, Qualification and Validation team, you will contribute to ensuring that equipment, utilities and facilities meet regulatory (GMP) and quality requirements throughout the project lifecycle. Your main responsibilities will include:

  • Drafting and reviewing CQV documentation (URS, protocols, reports: IQ, OQ, PQ)
  • Coordinating and/or executing commissioning and qualification activities for equipment, utilities and facilities
  • Ensuring compliance with GMP requirements and internal quality standards
  • Managing deviations, investigations and change controls related to CQV activities
  • Collaborating with Engineering, Quality, Production and Automation teams
  • Supporting audits and regulatory inspections
  • Tracking project timelines and reporting on CQV activities progress
Profil

Your Profile

  • Degree in Engineering, Life Sciences, or a related field
  • Proven experience in CQV within the pharmaceutical or biotech industry
  • Solid knowledge of GMP requirements and the validation lifecycle (ASTM E2500 / FDA / EMA guidelines)
  • Fluent in English; French and/or Dutch is a plus
  • Rigorous, autonomous, and comfortable working in a cross-functional environment
  • Strong communication and documentation skills
  • The opportunity to work on high-impact projects with a major player in the pharmaceutical industry
  • A career partner that adapts to your goals, your pace and your professional project
  • A team of passionate consultants dedicated to the health industry
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