Job Description
Yacht Life Sciences has a vacancy for an Equipment Life Cycle Specialist to work at Janssen Biologics in Leiden.
We are looking for an Equipment Life Cycle Specialist who has demonstrable experience and affinity with implementing equipment in a laboratory environment. Furthermore, you need to be able to manage multiple issues, organize activities, prioritize, and maintain clear line of communication within the multidisciplinary 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.
Tasks and responsibilities:
- Responsible for 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).
- Responsible for documenting administrator procedures, technical installation procedures and maintenance procedures.
- Implementation of equipment within the agreed timelines
- 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 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
- Monitoring of projects & Managed service providers spend to stay within planned budget.
- Oversees communication between internal and external parties during the analytical equipment implementation process.
Functie-eisen
Job requirements
- Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly experienced in a similar position.
- Minimal 2 years of work experience in Pharma with GMP and automation skills
- Laboratory Experience is considered as 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 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
Competenties
Competencies
- 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
Arbeidsvoorwaarden
Terms of employment
We offer a challenging secondment position for 1 year, which allows you to work in a dynamic and international environment, ensuring diversity in your work and creating plenty of opportunities for personal development. Salary between 3400 and 4400 euro gross per 4 week period.
We will offer a competitive benefit package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and to become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers, you will be able to follow courses and training via our Yacht Academy in order to keep your knowledge and skills up-to-date, i.e. boosting your career through personal and scientific growth.
Bedrijfsinformatie
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.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.