Key Skills

Job Description

ELM Specialist Lead Location: Einsteinweg, Leiden Duration: 12 months Hours: 40 hours per week Work mode: Hybrid, 3 days on site, 2 days home Johnson & Johnson is currently seeking a Equipment Life Cycle management (ELM) Specialist to join our Biotherapeutics lab services department located in Leiden. Imagine your next role as an ELM Specialist Lead who has demonstrable experience and affinity with leading equipment introduction projects in a GMP environment roles and 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, requalification 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. how to succeed Master’s degree or bachelor’s degree (HBO) in Life Sciences or highly experienced in a similar position. Proven Project Management skills and experience. Proven work experience in Pharma with GMP and automation skills. Pro-active, works independently, takes actions in the absence of specific instructions, and can write protocols/reports, business correspondence, and procedures Experience in budgeting, resourcing, planning, and leading projects Laboratory Experience is considered a plus. A background with experience with (Computer) System Validation in a GxP environment is considered a plus Experience with the following softwares is considered a plus: Empower, Softmax pro, SDMS, Deskman, LIMS, 32Karat, Trackwise, Comet and KNEAT. 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 details This role offers a very competitive hourly rate. This contract will run for 1 year. Hybrid role - 3 days on-site, 2 days at home you are welcome here Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are. About Johnson & Johnson Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson. https://www.jnj.com/ application process We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. questions If you would like some additional information about the role please contact: [email protected] Diversity, Equity & Inclusion For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.

Core Responsibilities

The Equipment Life Cycle Management Specialist will lead end-to-end implementation, relocation, and decommissioning of laboratory systems in a GMP environment. They are responsible for managing project scope, budgets, and timelines while ensuring compliance with global standards and maintaining the equipment validation master plan.

Requirements

Candidates must hold a Bachelor's or Master's degree in Life Sciences and possess proven project management experience within the pharmaceutical industry. Strong knowledge of GMP, GxP, and automation, along with the ability to manage multidisciplinary projects and stakeholders, is required.