Equipment Life Cycle management Specialist

Vacature

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.
For our client Johnson & Johnson Innovative Medicine we are searching for an Equipment Life Cycle management Specialist.

Keywords

• GMP
• Equipment Validation
• Implementation lab systems
• Project Management

As an Equipment Life Cycle management (ELM) specialist you will lead multiple projects, organize activities, prioritize work, and maintain clear line of communication within multidisciplinary (project) teams. Data integrity, mapping data flow, setting up and maintaining computerized systems are examples of ELM activities in support of well-functioning laboratories. You will also contribute to maintaining cGMP compliance and support the LEAN status of the team.

Main Responsibilities:

• Lead end-to-end implementation of lab systems across teams, from standalone analytical equipment to global platform projects;
• Be responsible for multiple multidisciplinary equipment introduction, relocation, re-qualification and decommissioning projects concurrently, from initiation to closure.
• Define project scope, budgets, resourcing, planning, and stakeholder management, and monitor execution to meet agreed timelines.
• Document and standardize administrator, installation, and maintenance procedures; ensure compliance with USP, GAMP, GMP, and ERES.
• Collaborate on Lab Systems initiatives with the global organization and maintain the equipment validation master plan (inventory, qualification status, and related data).
• Engage with vendors to understand and implement new technology versions, ensuring reliability and performance, while coordinating internal and external communications during implementation
• 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.

Profiel

The ideal candidate for this position should have a Life Sciences degree (Master’s or Bachelor/HBO) with a strong background in GMP-regulated pharmaceutical environments and automation. A background with experience with (Computer) System Validation in a GxP environment is considered a plus. Also experience with the following software is considered a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Comet and KNEAT.
You are a pro-active and independent professional with proven project management skills, able to write protocols, reports, procedures, and manage planning, budgeting, and resourcing. You have strong analytical and problem-solving abilities, with the capability to communicate effectively across all organizational levels (in English and preferably also in Dutch).

Arbeidsvoorwaarden

Contract for at least one year
Salary: 50000
Days of leave: 36
See here our other employment terms for this vacancy

Bedrijfsprofiel

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Contact

Interested? Send us a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form. (See URL) (Vacancy number A-2-2600018)