Freelance Life Cycle Management Specialist

4 weken geleden

Leiden, Zuid-Holland, Nederland Yacht Voltijd
{"title": "Job Description", "content": "Job Summary

Yacht Life Sciences is seeking an experienced Engineer to join our team as a Life Cycle Management (LCM) specialist. The successful candidate will be responsible for managing multiple projects and initiatives, ensuring compliance with GMP/ISO regulations and product design changes.

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 labelling design projects, working closely with global and local teams to ensure labels meet regulatory and marketing requirements.
  • Work with design teams to confirm manufacturing bill of material, coordinate BOM drawing, and cooperate with local engineering teams on BOM change and management.
  • Represent the Labelling COE to customer groups and functional business partners, responding to and escalating as needed.
  • Manage Unique Device Identification (UDI) applications and ensure all product UDI complies with local regulatory requirements.
  • Oversee design change projects, working closely with local and global teams to track progress.
  • Organize review meetings to identify process and risks, including risk mitigation.
  • Follow Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies, and Federal, State, and Local Government Regulations.
  • Write, develop, and implement validation procedures.
  • Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department.
  • Review and analyze data, understanding statistics and applying statistical data to determine normal and non-normal data along with probable causes of non-normal results.
  • Demonstrate independent understanding and application of core GMP fundamentals, including Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
  • 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.
Requirements
  • 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 labelling in a medical device environment preferred.
  • Fluent and excellent English reading, listening, writing, and speaking.
  • Experience in collaboration within a team environment across multiple time zones.
  • Experience in LCM (lifecycle management) or NPI (new product introduction) or product development.
  • Med. tech experience.
", "lang_code": "en"}

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