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ELM SPOC Analyst
Janssen Biologics is currently recruiting an Equipment Life Cycle Specialist / Coordinator within our QC department to strengthen our team. The successful candidate will have a background in the biologics/pharmaceutical/manufacturing industry as well as a relevant Bachelor / academic background.
The Coordinator will act as a Single Point of Contact within QC regarding Equipment (de)commissioning topics, such as, budget, priorities, compliance status. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.
About the Company:
Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is focused on the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, hardworking and multi-scaled people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.
Tasks and responsibilities
Responsible for the implementation of new systems in the QC laboratories. Lab systems vary from (standalone) analytical equipment to complex global platform projects which connect to LIMS (Laboratory Information Management Systems).
Implementation of equipment within the agreed timelines
Takes part in Lab Systems initiatives and projects, in partnership with the global organization and in alignment with business needs.
Informing 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).
Accountable for maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as the need arises).
Engages with equipment vendors to understand and implement new versions of technology in service of improving reliability and performance
Monitoring of projects & Managed service providers spend to stay within planned budget.
Leads all aspects of communication between internal and external parties during the analytical equipment implementation process.
Forecasting and business planning for new / desired future lab equipment & systems in collaboration with the partners (lab managers, program leads).
Continuously improves capabilities and expands responsibilities within the lab
Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly qualified in a similar position.
Minimal 4 years of work experience in Pharma with GMP and automation skills
A background with experience with (Computer) System Validation in a GxP environment is considered a plus
Experience with the following software is considered as a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Compliancewire.
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 highly desirable
Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence and procedures
This is an opportunity to work with a highly motivated team and to be a member of a Johnson & Johnson company, with an excellent record in employee continuous professional development and business improvement.
We are passionate about our work; we play vital roles across a range of professional subject areas and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers.
Whether you’re one of the ~1000 people who work here, or you’re considering joining the team, we offer:
Flexible working hours
An opportunity to be part of a global market leader.
A dynamic and inspiring working environment.
Opportunities to work on challenging projects and assignments
Possibilities for further personal and professional development/education
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Netherlands-South Holland-Leiden- Organization
Janssen Biologics (7266) Job Function
Quality Requisition ID
Open Positions from Johnson & Johnson Family of Companies