Job description
We are looking for a Validation Engineer to support our activities in the pharmaceutical sector. You will be responsible for ensuring the qualification and validation of critical process parameters and systems, following industry and client standards.
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Your missions
* Commissioning and Qualification:
o Review IQOQ protocols and reports to ensure the qualification of CPP.
o Support the team in creating risk analyses (SRA).
o Review equivalence certificates.
o Write validation plans.
* Validation:
o Design validation strategies through PQ protocol drafting according to internal standards.
o Ensure readiness for PQ validation.
o Coordinate validation activities on the floor.
o Manage unplanned events related to validation.
o Act as the point of contact with QC.
* Product Validation:
o Understand the product validation lifecycle and ensure alignment with the product strategy.
o Support the Product Steward in product-related topics (E&L, holding time, etc.).
* Change Control:
o Assess validation impact through eCC assessment (Stakeholder role).
o Coordinate eCC and manage associated tasks.
* Project Management:
o Plan and manage PQ activities (materials, documentation, personnel).
o Support project planning and lead meetings/workshops.
o Assist production representatives in understanding validation requirements.
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Your profile
* University degree in Biotechnology, Agronomy, Chemistry, or Pharmacy.
* Minimum of 5 years’ experience in a pharmaceutical environment within quality or validation.
* Fluent in French and English (oral and written).
* Solid knowledge of GMP environments related to validation activities.
* Strong interpersonal skills and a collaborative mindset.
* Excellent organizational and problem-solving abilities.
* Achievement-oriented and able to work under pressure on multiple deliverables.
* Proactive and able to make decisions in challenging situations.
* Knowledge of freeze dryers, filling lines, and isolators is a plus.
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What we offer
* Dynamic and multicultural environment with international exposure.
* Continuous learning through the Amaris Academy, providing certifications and training opportunities.
* Clear career development paths with both vertical and horizontal mobility.
* Opportunity to work on prestigious projects in the pharmaceutical and biotechnology sectors.
* Regular follow-ups, mentoring, and a people-first management culture.
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At Amaris Consulting, we believe in the power of diversity and inclusion. We are committed to creating a workplace that celebrates individuality and fosters equality. Everyone is welcome — regardless of age, origin, gender, identity, or belief.