Elm Analist

Equipment Life Cycle (ELM) Specialist with the department Qc Lab Services (PG24)

Location: Leiden, Netherlands

Contract: Full Time/Contract

Department: JSC Quality (CV19

Janssen Biologics is currently recruiting 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. The whole ELM team consists of approximately 10 FTE’s, is part of the Qc Lab Services department

About the Company:
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 include 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 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 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.

As a ELM Specialist, you will be responsible for the following tasks:

- 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 projects 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 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
- Oversees 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 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 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.
- 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