Johnson & Johnson
Imagine your next role as an Equipment Life Cycle (ELM) Specialist within our Quality Control (QC), which has a key role in supporting the testing teams by maintaining and introducing laboratory systems and equipment.
About the department.
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production, and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, dedicated and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are key.
The Janssen Supply Chain includes the Leiden QC large molecule laboratory, which is divided into various testing laboratories and supporting departments based on specific techniques and expertise. One of the unique features of Leiden QC is its role as a global HUB for stability testing. The test labs receive support from the Lab Services Team, which provides a wide range of services.
We are looking for an Equipment Life Cycle (ELM) Specialist who has demonstrable experience and affinity with leading equipment introduction projects in GMP environment.
As an ELM specialist, you need to be able to lead multiple projects, organize activities, prioritize, and maintain a clear line of communication within the multidisciplinary (project)teams. 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 implementation of new systems within the organization in collaboration with other teams. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems).
Leading multiple multidisciplinary equipment introduction and decommissioning projects from start to end simultaneously.
Defining the project scope, budget estimate and control, resourcing, planning, stakeholder management, leading, and monitoring projects within the agreed timelines.
Documenting 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.
Informing lab managers/supervisors of required corrective actions after the 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 the technology in service of improving reliability and performance
Oversees communication between internal and external parties during the analytical equipment implementation process.
To be successful in this role you have:
Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly experienced in a similar position.
Minimal 4 years of work experience in Pharma with GMP and automation skills.
Proven Project Management skills and experience.
Experience in budgeting, resourcing, planning, and leading projects
Laboratory Experience is considered a plus.
A background with experience with (Computer) System Validation in a GxP environment is considered a plus
Experience with the following software is considered a plus: Empower, Softmax Pro, SDMS, Deskman, LIMS, 32Karat, and Trackwise.
Ability to engage with personnel at all levels within the organization, to build and maintain fruitful relationships
Written and oral communication skills in English. Dutch is desirable
Planning skills, ability to prioritize multiple commitments
Analytical thinking and (technical) problem-solving. Lean/Six Sigma experience is desirable
Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence, and procedures
This role offers a very competitive hourly rate & a supportive working environment. This contract will run initially for 12 months.
you are welcome here
Janssen is an innovative pharmaceutical company: we work every day on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to optimally develop your career.
Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen.
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
If you would like some additional information about the role please contact: email@example.com
Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment 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 in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!