We are looking for an Equipment Life Cycle Specialist who has demonstrable experience and affinity with implementing equipment in a GMP 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.
- 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.
Modis is part of the Adecco Group and is the Professional Staffing/Consulting group and we have Consultants in our team who we second to clients. Currently it employs 500 consultants in the Netherlands and 20,000 worldwide. The focus of Modis Life Sciences is mainly in the direction of QA, QC, PV, RA, R&D and process profiles within an organization in the field of Biotech, Pharmaceutical industry and Food. We have Consultants working at EMA, Janssen, Sanquin, Astellas, Unilever, Corbion, MSD, Aspen and many more!
We have an exciting new job opportunity as a QC Equipment Lifecycle Analyst at our pharmaceutical client based in Leiden.
Functie-eisen• 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
- 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
- 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
If you wish to receive more information first, please contact the Modis Life Science team on firstname.lastname@example.org.