Jobid=d3dfd84139ba (0.0996)
Equipment Life Cycle Management (ELM) Specialist
Location: Leiden
Contract: 12 months
Hours: 40 hours per week
Department: Biotherapeutics Lab Services
About Johnson & Johnson
The Role
Key Responsibilities
- Lead end-to-end implementation of laboratory systems across teams, ranging from standalone analytical equipment to complex global platform initiatives.
- Manage multiple equipment-related projects concurrently, including introduction, relocation, requalification, and decommissioning, from initiation to closure.
- Define project scope, budgets, resource allocation, planning, and stakeholder management; monitor execution to ensure timely delivery.
- Create, standardize, and maintain administrator, installation, and maintenance procedures in compliance with USP, GAMP, GMP, and ERES requirements.
- Contribute to and maintain the Equipment Validation Master Plan, including inventory, qualification status, and related data.
- Collaborate on global Lab Systems initiatives and support alignment with corporate standards.
- Engage with equipment vendors to evaluate and implement new technology versions, ensuring performance, reliability, and seamless integration.
- Coordinate internal and external communication during analytical equipment implementation processes.
- Support activities related to data integrity, dataflow mapping, and setup of computerized laboratory systems.
Qualifications
- Master's degree or Bachelor's (HBO) in Life Sciences, or equivalent experience in a similar role.
- Proven experience in the pharmaceutical industry with strong knowledge of GMP and laboratory automation.
- Demonstrated project management skills, including planning, budgeting, and stakeholder coordination.
- Proactive mindset with the ability to work independently and make decisions in the absence of specific instructions.
- Strong writing skills for drafting protocols, reports, correspondence, and procedures.
- Laboratory experience is considered an advantage.
- Experience with (Computer) System Validation in a GxP setting is a plus.
- Experience with the following software is advantageous:
Empower, SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, TrackWise, Comet, KNEAT. - Strong interpersonal skills with the ability to engage stakeholders at all organizational levels.
- Excellent written and verbal communication skills in English; Dutch is preferred.
- Strong planning, prioritization, analytical, and technical problem‑solving skills.
- LEAN or Six Sigma experience is desirable.
Let op: vacaturefraude
Deel deze vacature: