Life Cycle Management Engineer
3 weken geleden
Yacht Life Sciences is seeking a highly skilled Freelance Engineer Life Cycle Management to join our team at Johnson & Johnson /Mentor Medical BV in Leiden. As a Freelance Engineer Life Cycle Management, you will be responsible for managing multiple projects and initiatives, ensuring compliance with GMP/ISO standards, and collaborating with cross-functional teams to achieve process improvements, cost reductions, and quality enhancements.
Key Responsibilities:- Manage and execute projects of high complexity, ensuring safety, regulatory compliance, and business needs are met.
- Provide technical support and coordination between component sourcing and suppliers for new material cut-in and old material phase-out activities.
- Lead labeling design projects, working closely with global and local teams to ensure labels meet regulatory and marketing requirements.
- Collaborate with design teams to confirm manufacturing bill of material, coordinate BOM drawing, and manage BOM changes.
- Represent the Labelling COE to customer groups and functional business partners, responding to and escalating requests as needed.
- Manage Unique Device Identification (UDI) applications and ensure compliance with local regulatory requirements.
- Oversee design change projects, working closely with local and global teams to track progress and identify process risks.
- Develop and implement validation procedures, ensuring compliance with SOPs, GMPs, and Company Policies.
- Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department.
- Analyze data, understanding statistics and applying statistical data to determine normal and non-normal results.
- Demonstrate independent understanding and application of core GMP fundamentals, including Data Integrity, Good Manufacturing Practices, and Good Documentation Practices.
- Communicate business-related issues or opportunities to next management level.
- Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
- Bachelor or Master Degree in Engineering, Biochemistry, Pharmacy, Biotechnology, Science, Innovation, Engineering, or equivalent.
- A minimum of 6-8 years' work experience in engineering and/or package labeling in a medical device environment preferred.
- Fluent and excellent English reading, listening, writing, and speaking skills.
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