Life Cycle Management Engineer

4 weken geleden

Leiden, Zuid-Holland, Nederland Yacht Voltijd
About the Company

Yacht Life Sciences is a renowned partner for companies in the life sciences industry, providing access to a network of professionals and companies that share knowledge and opportunities.

Our client, Johnson & Johnson, is a global leader in the development, production, and marketing of vaccines and antibodies to prevent and combat infectious diseases.

Job Description

We are seeking an experienced Life Cycle Management Engineer to join our team at Johnson & Johnson's Leiden site. As a key member of our team, you will be responsible for managing multiple projects and initiatives, ensuring compliance with GMP/ISO regulations and product design changes.

Key responsibilities include:

  • Leading high-level site products design change, identifying and following quality processes and procedures.
  • Supporting new product registration and commercial launch, identifying key steps and leveraging global resources.
  • Providing required documentation and labelling change deliverables to lifecycle design control teams.
  • Maintaining product master date and change.
  • Reacting to product issues in the market, coordinating between Research & Development, Marketing, and Regulatory Affairs teams.

Additional responsibilities include:

  • Managing and executing projects and/or programs of high-level complexity, ensuring safety, regulatory compliance, company standards, operation requirements, and business needs are met.
  • Providing technical support and coordinating between component sourcing and suppliers for activities of new material cut-in and old material phase-out.
  • Leading labelling design projects, working closely with global and local teams to ensure labels meet regulatory and marketing requirements.
  • Working with design teams to confirm manufacturing bill of material, coordinating BOM drawing, and cooperating with local engineering teams on BOM change and management.
  • Representing the Labelling COE to customer groups and functional business partners, responding to and/or escalating as appropriate within the labelling COE to meet needs and respond to request escalations and inquiries from the business.
  • Managing Unique Device Identification (UDI) application and management, ensuring all product UDI complies with local regulatory requirements.
  • Overall management of design change projects, working closely with local and global teams to track project progress.
  • Organizing review meetings to identify process and risks, including risk mitigation.
  • FOLLOWING Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies, and Federal, State, and Local Government Regulations.
  • Writing, developing, and implementing validation procedures.
  • Complying with J&J Safety Requirements and ensuring safe working conditions and practices in the department.
  • Reviewing and analyzing data, understanding statistics, and applying statistical data to determine normal and non-normal data along with probable causes of non-normal results.
  • Demonstrating 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).
  • Communicating business-related issues or opportunities to next management level.
  • Ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
Requirements

We are looking for a highly skilled and experienced Life Cycle Management Engineer with:

  • 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.
  • 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.
Terms of Employment

We offer a challenging position in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development.

This concerns a secondment contract for one year via Yacht with an initial assignment for 1 year at Mentor Medical BV / Johnson & Johnson.

We will offer a competitive benefit package in line with the seniority of the position, with a salary between 4300 and 5500 euro gross per 4-week period (based on full-time employment).

Working full-time is preferred (32 or 36 hours can be discussed).

Hybrid work, expectation is to be working from the office.

  • Freelance Engineer Life Cycle Management

    3 weken geleden

    Leiden, Zuid-Holland, Zuid-Holland, Nederland Yacht Freelance Voltijd

    Job DescriptionYacht 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 w

  • Freelance Engineer Life Cycle Management

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Freelance Voltijd

    Job DescriptionYacht 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...

  • Freelance Engineer Life Cycle Management

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Voltijd

    Job DescriptionYacht 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...

  • Freelance Life Cycle Management Specialist

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Voltijd

    {"title": "Job Description", "content": "Job SummaryYacht 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 ResponsibilitiesManage...

  • Product Life Cycle Manager

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Voltijd

    Job DescriptionYacht Life Sciences is seeking an experienced Product Life Cycle Manager to join our team at Johnson & Johnson/Mentor Medical BV in Leiden. As a key member of our team, you will be responsible for managing the life cycle of products, from design to launch and beyond.Key Responsibilities:Manage and execute projects and/or programs of high-level...

  • Equipment Life Cycle Specialist

    6 dagen geleden

    Leiden, Zuid-Holland, Nederland Johnson & Johnson Voltijd

    We are seeking an experienced Equipment Life Cycle Specialist to join our team at Johnson & Johnson. The successful candidate will be responsible for leading multiple equipment introduction and decommissioning projects from start to end, ensuring compliance with GMP regulations. Key responsibilities include defining project scope, budget, and timelines, as...

  • Research Assistant

    6 dagen geleden

    Leiden, Zuid-Holland, Nederland Universiteit Leiden Voltijd

    Job DescriptionUniversiteit Leiden is seeking a highly skilled Research Assistant to join our team. The successful candidate will be responsible for formatting and uploading data on aquatic foods to the HESTIA platform. This is a unique opportunity to contribute to advancements in life cycle assessment and environmental impact analysis.Key...

  • WO Stage Life Sciences Engineer

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Mijn Stage bij KuijpersBen jij een ambitieuze en proactieve WO-student met een passie voor technologie en innovatie? Kuijpers PHF Services biedt een geweldige kans om praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende omgeving.VerantwoordelijkhedenLiteratuuronderzoek doen naar recente ontwikkelingen in...

  • Life Sciences Professional

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Voltijd

    Join a Strong Professional NetworkAs a member of our professional network, you will have the opportunity to interact with colleagues who share your education, ambitions, and competencies. This will enable you to become a part of the Yacht network, which spans the Life Science industry. You will be challenged by your peers and will be able to follow courses...

  • Freelance Maintenance Engineer

    3 dagen geleden

    Leiden, Zuid-Holland, Zuid-Holland, Nederland Yacht Freelance Voltijd

    Yacht Life Sciences heeft een vacature voor een Maintenance Engineer voor Johnson & Johnson Innovative Medicine in Leiden.Essentiële taken en verantwoordelijkheden:Als maintenance engineer heb je een breed takenpakket waarbij je je zowel met preventief en correctief onde

  • WO Stage Life Sciences Engineer

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Mijn Stage bij KuijpersBen jij een ambitieuze en proactieve WO-student met een passie voor technologie en innovatie? Kuijpers PHF Services biedt een geweldige kans om praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende omgeving, waarbij ruimte is om stageopdrachten vanuit je studie te integreren.We zijn...

  • Management Traineeship bij Eurofins

    2 weken geleden

    Leiden, Zuid-Holland, Nederland Eurofins Netherlands BioPharma Product Testing Voltijd

    Management Traineeship bij EurofinsWe zijn op zoek naar ambitieuze starters die zich willen ontwikkelen tot leidinggevende professionals in de life sciences sector. Als Management Trainee bij Eurofins zul je deel uitmaken van een dynamische en innovatieve organisatie die wereldwijd marktleider is op het gebied van bio-analytische testen.Wat ga je doen?Als...

  • Technisch Specialist Life Sciences

    3 dagen geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Mijn stage bij KuijpersBen jij een ambitieuze en proactieve WO-student met een passie voor technologie en innovatie? Kuijpers PHF Services biedt een geweldige kans om praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende omgeving, waarbij ruimte is om stageopdrachten vanuit je studie te integreren.Kuijpers...

  • Stageplaats in Life Sciences Innovatie

    2 maanden geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Over de Stage Ben jij een gedreven en initiatiefrijke WO-student met een sterke interesse in technologie en innovatie? Kuijpers PHF Services biedt een unieke kans om waardevolle praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende setting, waarbij je de mogelijkheid hebt om stageopdrachten vanuit je...

  • Technische stagiair Life Sciences

    1 week geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Mijn stage bij KuijpersWe bieden een geweldige kans om praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende omgeving.Kuijpers PHF Services ontwerp, bouwt en onderhoudt onderzoeks- en productiefaciliteiten voor de Life Sciences & Hightech branche.Als stagiair binnen ons engineeringsteam zal je onderzoek...

  • WO Stage Life Sciences: Technologie en Innovatie

    2 maanden geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Over Kuijpers PHF ServicesKuijpers PHF Services is een expert in de Life Sciences & Hightech branche. Wij ontwerpen, bouwen en onderhouden onderzoeks- en productiefaciliteiten voor de Life Sciences & Hightech branche. Faciliteiten waarin bijvoorbeeld productie van geneesmiddelen, medische hulpmiddelen en complexe hightech producten...

  • WO Stage Life Sciences Engineer

    4 weken geleden

    Leiden, Zuid-Holland, Nederland Kuijpers Voltijd

    Mijn Stage bij KuijpersBen jij een ambitieuze en proactieve WO-student met een passie voor technologie en innovatie? Kuijpers PHF Services biedt een geweldige kans om praktijkervaring op te doen en je vaardigheden verder te ontwikkelen in een dynamische en vooruitstrevende omgeving.Wat ga je doen?Als stagiair binnen ons engineeringsteam zal je onderzoek doen...

  • Asset Manager

    2 maanden geleden

    Leiden, Zuid-Holland, Nederland Kracht Recruitment Voltijd

    About the RoleWe are seeking an experienced Asset Manager to join our team at Kracht Recruitment. As an Asset Manager, you will be responsible for managing, structuring, and qualifying contractual, technical, and financial preparations. You will also be responsible for monitoring performance contracts and providing operational management for large,...

  • Equipment Lifecycle Manager

    3 weken geleden

    Leiden, Zuid-Holland, Nederland Yacht Voltijd

    Job Title: Equipment Life Cycle SpecialistYacht Life Sciences is seeking an experienced Equipment Life Cycle Specialist to join our team at Janssen Biologics in Leiden. As an Equipment Life Cycle Specialist, you will be responsible for implementing new systems within the organization, collaborating with other teams, and ensuring compliance with regulations...

  • Data Engineer Internship

    1 maand geleden

    Leiden, Zuid-Holland, Nederland RandStad Voltijd

    Job DescriptionWe are seeking a highly motivated and enthusiastic intern to join our Manufacturing Automation and Data Engineering team. As an intern, you will have the opportunity to work on exciting projects that focus on data-driven manufacturing process optimization.ResponsibilitiesSupport the implementation, validation, and maintenance of manufacturing...