Validation Engineer

Sep 30, 2021

Job Description

40+ is the dedicated number of team members you would be joining at IDB (Advanced Accelerator Applications, Netherlands) whose mission is to bring new therapies to patients wordwide by producing radiopharmaceuticals for targeted radioligand therapy. IDB 's team embraces the culture of empowerment and team work.

Validation Engineer will be responsible for authoring protocols and reports regarding:
• new or modified process equipment qualification,
• process & sterilization validation.
• building & utility validation,
as well as execution of the required tests in collaboration with Production department or external suppliers where applicable. They will initiate, execute and report the Ongoing Process Verification (OPV) program and Periodic Review program ensuring that all activities are documented and executed according to cGMP and quality requirements.

Some of the main responsibilities include:
Commissioning, Qualification and Validation
• Prepares protocols for qualification (IQ, OQ, PQ) of new or modified process equipment, process and sterilization validation and building & utility validation.
• Executes (re)-qualification/validation tests in collaboration with Production department or accompanies external suppliers when performing (re)-qualification/validation tests
• Authors qualification/validation reports and analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Initiates, executes and reports the Ongoing Process Verification (OPV) program by establishing the Monitoring Plan and performing periodic evaluations
• Initiates, executes and reports the Periodic Review (PR) program by establishing the approach and performing periodic evaluations

General tasks
• Supports deviations, investigations, audits upon request

Strategy & Organizational Development:
• Mission & Vision of Engineering department
• Ensure availability of competent, high performing people and develop the talent pool and/or succession plan.
• Inspection readiness of Engineering department
• Support internal and external audits
• Ensure Compliance with Quality Manual / Quality Modules / GOPs / NMM etc.
• Implement standards
• Implement GOPs
• If needed, create regional / site SOPs & templates
• Implement sharing and leveraging of best practices and expertise
• Own the Training Curriculum for own Job Profile

Maintenance & Calibration:
• Contributes to root cause investigations and audits upon request
• Authors and updates SOPs, WIs when required
• Ensures Good Documentation Practices are applied

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Education: Degree in Engineering, Medical/Pharmaceutical sciences, Biotechnology (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent.

Languages: Fluent in Dutch and English (writing, reading and speaking)

Relevant Experiences: >2 years of pharmaceutical industry experience in a technical/validation role is preferred
• Basic knowledge of radioactivity, radioprotection, pharmaceutical and clean room environment constraints, as well as production processes is preferred
• Project Management skills in order to execute multiple tasks in parallel
• IT skills
• Analysis capability and reporting skills
• Able to work in a multi-disciplinary environment/team
Technical Operations
Full Time
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Validation Engineer

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