Software Engineer II developing end - to - end software for the dental industry. Joining a new team focused on innovative product launches and process efficiency.
About the role
- Senior Engineer managing lifecycle for pharmaceutical delivery devices within supply chain. Collaborating with teams on compliance and continuous improvement initiatives in Belgium and Switzerland.
Responsibilities
- Lead lifecycle management activities for delivery devices constitute.
- Assess and validate materials for pharmaceutical products, ensuring compatibility, protection, and safety.
- Provide technical support for change control, investigations, CAPA, and process improvements.
- Ensure compliance with cGMP and regulatory requirements (CFR Parts 3, 4, 11, 210, 211, 820).
- Support validation activities and production processes at suppliers and manufacturing sites.
- Collaborate with cross-functional teams to enable technology transfers and process scale-up.
- Drive sustainability initiatives and continuous improvement projects.
- Apply project management methodologies (FPX, Six Sigma) to optimize design and reduce cost of goods.
- Communicate project objectives and updates to stakeholders.
Requirements
- Bachelor’s degree in Engineering or related discipline (Packaging preferred); MS or MBA desirable.
- Experience in primary container engineering/design and pharmaceutical manufacturing processes.
- Knowledge of primary packaging equipment and validation requirements.
- Familiarity with container closure systems (glass syringes, vials, bottles, blisters).
- Understanding of temperature-controlled chain distribution for pharmaceuticals.
- Strong analytical skills with ability to interpret data and apply statistical techniques.
- Excellent communication and collaboration skills with internal and external stakeholders.
- Proven compliance expertise in FDA and ISO standards.
Benefits
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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