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.
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