Equipment Life Cycle Data Integrity Specialist

Equipment Life Cycle Data Integrity (ELM-DI) Specialist with the department QC Lab Services

Location: Leiden, Netherlands - Hybrid working - 3 days a week on site

Duration: 12 months

Hours: 40 hours a week

Janssen Biologics is currently recruiting an Equipment Life Cycle (ELM) Data integrity Specialist within our Quality Control (QC), which has a key role in supporting the team with set up/maintain of data integrity compliance w.r.t introduction, requalification of existing laboratory systems and equipment. 

About the Company:

J& J Innovative medicine 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) Data integrity Specialist who has demonstrable experience and affinity with leading equipment introduction projects in GMP environment. 

As an ELM DI 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.

roles and responsibilities

• Drafting and supporting revision of data governance related work instructions / SOPs

• Data integrity / data governance related instrument assessments and remediation

• Planning and coordinating qualification activities for laboratory equipment in compliance with current GMP and regulatory requirements

• Preparation and execution of change control records related to equipment lifecycle management

• Installation, configuration, testing and maintenance of application software and system management tools

• Definition of requirements for new software applications, analysis of process and data flow and creation of corresponding flowcharts

• Maintenance of security, backup, and recovery strategies for databases and other data systems

• Support with the investigation into deviations caused by non-conforming software and implement solutions (CAPA)

• Liaise with vendors and other IT personnel for problem resolution (e.g., technical support for manufacturer qualifications, maintenance & calibration, troubleshooting and investigations)

• The implementation of 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.

• Involved in maintaining the equipment validation master plan for QC equipment (inventory, qualification status, additional information as required).

• 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.

• Minimal 4 years of work experience in Pharma with GMP.

• Previous Training and Experience in Data Integrity / Governance in GMP environment (Part 11 / Annex 11)

• Qualification Experience (GMP, preferable for laboratory equipment / CSV)

• Excellent communication skills

• Hands on experience with instrument or software qualification and documentation (e.g., CSV, qualification of production plants, laboratory equipment)

• Experience in project management

• Experience with COMET, SAP and TruVault is an advantage

• Very good knowledge of Microsoft Office programs (Outlook, Word, Excel, PowerPoint)

• 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 

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

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 Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

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. 

• English CV only

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”.