Process Validation Specialist

Gi Group; Wallis; Vor Ort; CHF 80’000 - 110’000; Vollzeit

Zusammenfassung

An innovative biopharmaceutical partner is seeking a Process Validation Specialist for a temporary 6-month contract. In this pivotal role, you will design and implement process validation strategies, ensuring compliance with regulatory standards. You will collaborate closely with R&D teams, oversee validation assessments, and maintain a detailed continued process verification plan. This position offers a unique opportunity to contribute to cutting-edge projects in a dynamic environment. If you have a strong background in chemistry or biotechnology and a passion for quality assurance, this role is perfect for you.

Qualifikationen

• Master's degree in relevant scientific fields is essential.
• Experience in project management and regulatory interactions is preferred.

Aufgaben

• Design and prepare validation documents for processes.
• Support R&D teams during process characterization phases.

Kenntnisse

Project Management

Regulatory Interaction

Process Validation

Quality Assurance

Ausbildung

Master in Chemistry

Master in Biology

Master in Biotechnology

Master in Chemical Engineering

Jobbeschreibung

For our biopharmaceutical partner, Gi Life Sciences is looking for a :

Process Validation Specialist

(Temporary Contract – 6 months)

Your responsibilities:

• Design of the process validation strategy, preparation of validation documents (study design / writing protocols and reports)
• Supporting R&D teams during the process characterization phase
• Reviewing and approving of process characterization documents
• Responsibility for the validation assessment on changes and deviations (approval of deviation and changes)
• Preparation and maintenance of a detailed continued process verification plan
• Assessing and approving of Product Quality Reviews

Your profile:

• Master in Chemistry, Biology, Biotechnology, chemical engineering or equivalent
• Experience in project management, preferable in Operations, MSAT, Quality and Compliance
• Experience in interaction with regulatory agencies (Swiss medic, FDA etc.) would be an advantage
• First experience in mammalian is an advantage
• Languages: English. German is an asset

Your contact at Gi Group : Anaïs Mieszczak