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Antwerpen - Contracting
Launch Excellence Project Engineer
Functieomschrijving
The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site.
The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle.
The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation.
Key Responsibilities:
The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle.
The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation.
Key Responsibilities:
- Validation Activities
- Plan, execute, and document validation activities associated with new product introduction.
- Validate processes related to: formulation, filling, shipping, packaging
- Ensure validation documentation complies with GMP and regulatory standards.
- Execute and document urgent quality investigations.
- Analyze deviations, identify root causes, and implement corrective actions.
- Ensure traceability and documentation of all investigations.
- Conduct risk assessments for processes and systems.
- Identify potential risks related to product implementation.
- Define and implement risk mitigation strategies.
- Support process changes and system updates related to new product introduction.
- Collaborate with cross-functional teams to implement improvements.
- Coordinate project activities related to product launch.
- Plan timelines, deliverables, and project milestones.
- Track progress and resolve issues.
- Provide project status reporting to stakeholders.
- Prepare technical and validation documentation.
- Ensure documentation meets regulatory and internal quality requirements.
- Maintain organized and auditable project records.
Profiel
- Master’s degree in a scientific discipline
- Fluency in Dutch & English
- Validation processes and documentation
- Risk assessment methodologies
- Quality investigation and deviation analysis
- Knowledge of Good Manufacturing Practices (GMP)
- Project planning and coordination
- Technical report writing
- Work may require flexibility for shift work depending on project needs.
- Collaboration with multiple departments (quality, manufacturing, engineering, regulatory).
Aanbod
- Bedrijfswagen
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres