eLIMS Master Data Analyst

Johnson & Johnson Co.; Schaffhausen; Hybrid; CHF 83,000 - 124,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Johnson & Johnson Innovative Medicine is seeking an eLIMS CoE Master Data Analyst for QC Operations in a hybrid role (3 days on-site, 2 days WFH). The 12-month contract focuses on eLIMS data setups, instrument integration, and paperless operations across an international network including Schaffhausen.

You will maintain data quality, lead projects like iLABS implementations, and mentor team members while ensuring compliance with cGMPs and regulatory requirements.

Qualifications

• Minimum bachelor’s degree or equivalent education.
• 4–6 years of experience in a regulated medical industry with knowledge of LIMS and quality systems.
• Experience with analytical testing, paperless lab (iLABS), quality control or IT is preferred.
• Broad knowledge of cGMPs and applicable regulations (FDA, ICH Q8–Q10) and risk management.
• Strong written and verbal communication skills (English – B2).
• Ability to develop and provide training to colleagues and partners.

Responsibilities

• Work within the eLIMS CoE as an expert in data setups in the eLIMS system to support lab processes including paperless (iLAB), product release and CofA generations.
• Independently maintain and review high quality data setups, integrate instruments and applications, and translate specifications within the eLIMS system.
• Review and test system updates, create and manage system-related documents, and drive process improvements.
• Interact with IT and communicate with customers in business language.
• Take ownership by completing incoming requests in a timely manner.
• Understand site master data requirements and lab processes to ensure configurations are accurate and complete.
• Mentor, lead, and train team members.
• Lead projects within QC Operations, e.g. iLABS projects and standardization of processes.
• Maintain system documentation (procedures, events, etc) with TruVault, COMET, Confluence, q-Test or other systems.

Skills

LIMS knowledge

Quality systems

Regulatory domain knowledge

English proficiency (B2)

Education

Bachelor's degree or equivalent

Tools

iLABS

Job description

eLIMS CoE Master Data Analyst iLABS – QC Operations

Working mode: Hybrid, 3 days on-site and 2 days WFH

Duration: 12-month contract

Hours: 40 hours per week

Imagine your next project driving critical lab digital transformation as an expert in eLIMS data setups, instrument integration, and paperless operations across an international network.

The Janssen Supply Group, a member of the Johnson & Johnson family of companies, is recruiting for an eLIMS CoE master data Analyst iLABS, QC Operations. The team structure is a global team with members located in Schaffhausen, Leiden, Cork, and the US.

roles and responsibilities

• Work within the eLIMS CoE as an expert in data setups in the eLIMS system to support lab processes including paperless (iLAB), product release and CofA generations.
• Independently maintain and review high quality data setups, integrate instruments and applications, and translate specifications within the eLIMS system using current business processes.
• Review and test system updates, create and manage any system related documents, and identify and drive process improvements.
• Interact with IT and speak business language to customers.
• Take ownership by completing any incoming requests in a timely manner.
• Fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete in order to maintain high quality data.
• Mentor, lead, and train team members.
• Lead projects within QC Operations, e.g. implementation of iLABs projects, harmonization / standardization of processes.
• Maintain system related documentation (procedures, events, etc) with the appropriate applications (TruVault, COMET, Confluence, q-Test or any other designed system).
• Participate in pre CoC / Kick off meetings and manage the implementation activities of a change control.
• Participate in system related project activities including review and testing of system updates.
• Interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories.
• Maintain a clear line of communication with the eLIMS CoE lead.
• Maintain a high level commitment to meeting customer expectations as determined by the eLIMS CoE lead.

how to succeed

• Minimum bachelor's degree or equivalent education.
• Minimum of 4 – 6 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality systems.
• Extensive other experience with analytical testing, paperless lab (iLABS), quality control or IT is preferred.
• Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management.
• Demonstrated strong written and verbal communication skills (Basic in English – B2).
• Demonstrated ability to develop and provide training to colleagues and partners.
• Demonstrated flexibility in adapting to urgent needs.
• Ability to manage multiple issues, organize activities, prioritize, and elevate to management when appropriate.

This role offers a very competitive hourly rate. This contract will run for 12 months (with potential for extension)

you are welcome here

Johnson & Johnson Innovative Medicine 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.

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”.