ELM Analyst W

Description

Johnson & Johnson is recruiting an Equipment Life Cycle (ELM) Analyst within our Quality Control in Leiden.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where sophisticated diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Do you have proven experience and affinity with leading equipment introduction projects in an GMP environment? Are you able to lead multiple projects, coordinate activities, prioritize, and maintain a clear line of communication within multidisciplinary (project)teams? If this sounds like you to it all, then we are looking for you

What you will be doing:

You will have a key role in supporting the testing teams by maintaining and introducing laboratory systems and equipment. The whole ELM team consists of approximately 10 FTEs and is part of the QC Lab Services department. Data integrity, setting up and maintaining computerized systems as well as robotics are examples of Automation activities in support of well-functioning laboratories. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.

The responsibilities and the impact YOU will have:

• The implementation of new systems within the organization in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to sophisticated global platform projects which connect to LIMS (Laboratory Information Management Systems).
• Leading multiple multidisciplinary equipment introduction and decommissioning projects from start to end simultaneously. This includes defining the project's scope, budget estimate and control, resourcing, planning, stakeholder management, leading, and supervising projects within the agreed timelines.
• Detailing administrator procedures, technical installation procedures and maintenance procedures.
• Takes part in Lab Systems initiatives and projects, in cooperation with the global organization and in alignment with business needs.
• Advising lab managers / supervisors of required corrective actions after publication of new and/or modified regulations to ensure compliance status of existing and new systems (USP, GAMP, GMP, ERES).
• Involved in maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as required).
• Engages with equipment vendors to understand and implement new versions of technology in service of improving reliability and performance
• Coordinates communication between internal and external parties during the analytical equipment implementation process.

Qualifications

We would love to hear from YOU, if you have the following essential requirements:

• Master's degree or Bachelor's degree (HBO) in Life Sciences or highly expert in a similar position.
• Written and oral communication skills in English on a professional level.
• Minimal 4 years of work experience in Pharma with GMP and automation skills.
• Experience with the following software is considered as a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise.
• Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships including proven Project Management skills and experience.
• Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence and procedures.
• Experience with maintaining compliance regarding Quality, Investigations, Specialisations, and Audit.

This is what awaits YOU at J&J:

Competitive salary and extended benefits package.

A safe and controlled work environment crafted to support high-quality workmanship and compliance with industry standards.

Comprehensive training with an assigned buddy/mentor.

Opportunity to work with a dedicated and hard-working team.

What type of mark will you make?

By joining Johnson&Johnson you will find boundless opportunities to craft your path & amplify your impact inside & outside our walls. And with our dedication to be the world's healthiest workforce you can strengthen your body as well as your mind. When you work at Johnson&Johnson you can touch over a Billion of lives worldwide every day. And when you apply your talent to our collective purpose there's no end to the lasting impact we can make together. And that changes everything.

Diversity, Equity & Inclusion at Johnson&Johnson means that "YOU belong"

For more than 130 years, diversity, equity & inclusion have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our dedication to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to build an inclusive environment where a diverse set of backgrounds, perspectives and experiences are valued, and every one of our people feel that they belong and can reach their potential. No matter who they are.

Primary Location Europe/Middle East/Africa-Netherlands-South Holland-Leiden

Organization Janssen Biologics (7266)

Job Function Quality Control

Req ID: W