Junior Validation Engineer - GMP Sterile Filtration

StudentJob; Eindhoven; On-site; EUR 50,000 - 70,000; Full time

Job summary

TMC is an international high-tech consultancy. They seek a Validation Engineer to validate sterile filtration steps, align processes with Annex 1, and collaborate with the SSO Sterile Filtration, Quality, and production teams.

You will manage projects, write validation reports, and perform on-floor validation in GMP environments, contributing to the overall quality and efficiency of pharmaceutical production.

Qualifications

• Completed BSc/HBO with at least 2 years of relevant Biopharma GMP experience.
• Strong technical and scientific background with a process-oriented mindset.
• Willingness to combine project management and technical writing with hands-on activities.

Responsibilities

• Draft, execute, and monitor a detailed project plan for filter validation.
• Translate theoretical validation plans into practical on-floor validation approaches.
• Prepare, coordinate, execute, and report validation tests.
• Conduct paper-based assessments and physical validation studies in production environments and labs.
• Ensure execution and documentation in accordance with GMP guidelines.
• Identify and elevate technical, compliance, and planning risks and resolve them with Production, Quality, and the SSO.
• Identify opportunities to optimize the project substantively and organizationally.

Skills

Project management

Technical writing

Sterilization validation

GMP knowledge

Biopharma

English proficiency

Education

BSc/HBO degree in Biopharma or related field

Job description

TMC is an international high-tech consultancy. They seek a Validation Engineer to validate sterile filtration steps, align processes with Annex 1, and collaborate with the SSO Sterile Filtration, Quality, and production teams.

You will manage projects, write validation reports, and perform on-floor validation in GMP environments, contributing to the overall quality and efficiency of pharmaceutical production.