Job Description
Yacht Life Sciences has a vacancy for an Engineer LCM (life cycle management) to work at Johnson & Johnson /Mentor Medical BV in Leiden.
Under the direction of the applicable LCM Lead, manages most aspects of multiple projects or initiatives. Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Lead multifunctional, cross departmental projects and initiatives geared towards achieving process improvements, cost reductions, new process/product introductions and quality improvement.
Engineer LCM is a critical position to be responsible for site products and components life cycle management.
Staff Engineer LCM leads high-level site products design change, identifies, and follows appropriate quality processes and procedures.
Staff Engineer LCM support new product registration and commercial launch, identifies key steps and leverage global resources.
Staff Engineer LCM provides the required documentation and labelling change deliverables to lifecycle design control teams.
Staff Engineer LCM is responsible for product master date maintenance and change.
Staff Engineer LCM reacts to the product issues in market, and coordinate between Research & Development team, Marketing team and Regulatory Affairs to lead relevant projects.
Success depends on the depth of knowledge in design change process and the coordination with design team, New Product Introduction / Life Cycle Management team, Research & Development team, and other J&J manufacturing teams.
Other responsibilities of the Engineer LCM:
Under the direction of the applicable LCM lead and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Manages and executes projects and/or programs of high-level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.
Responsible for providing technical support and be coordinator between component sourcing and suppliers for activities of new material cut in and old material phase out.
Lead labelling design projects, work closely with global and local teams to make sure the labels meet regulatory and marketing requirements.
Work with design team to confirm manufacturing bill of material, coordinate BOM Drawing, and cooperate with local engineering team on BOM change and management.
Leading collaborative team meetings with cross-functional subject matter experts (SME) to arrive at consensus for labelling content changes. Under very limited to no supervision and at times independently coordinates lifecycle product labelling content input collection.
Represent the Labelling COE to customer groups, and functional business partners, while responding to and/or escalating as appropriate within the labelling COE to meet the needs and respond to request escalations and inquiries from the business, as needed.
Responsible for Unique Device Identification (UDI) application and management, make sure all product UDI complies with local regulatory requirement.
Overall management of design change projects. Work closely with local and global teams to track projects progress.
Organize review meetings to identify the process and risks, including risk mitigation.
Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
Writes, develops and implements validation procedures.
Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department.
Reviews and analyses data, understanding of statistics and the application of statistical data, able 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 but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Job 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.
Must have 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