Technical Expert eLIMS CoE QC Operations

Johnson & Johnson Innovative Medicine•Horsham, PA

2d•Remote

About The Position

This role is within the eLIMS Center of Excellence (CoE) and focuses on driving and shaping digital laboratory processes across global QC Operations. The Technical Expert in eLIMS will ensure high-quality data configurations to enable efficient, compliant, and paperless laboratory workflows, including product release and Certificate of Analysis generation. The position involves independent design, maintenance, and continuous improvement of data setups, ensuring alignment with business processes and regulatory requirements. This role acts as a liaison between business and IT, translating laboratory needs into system solutions. Responsibilities include integrating laboratory instruments and applications, reviewing and testing system updates, and maintaining system documentation and standards. The role also involves identifying process improvement opportunities, contributing to global harmonization and standardization, and taking ownership of incoming requests. A deep understanding of site-specific laboratory processes and master data requirements is necessary for accurate system configurations. The role will lead or contribute to projects within QC Operations, such as continuous improvement initiatives related to the iLAB’s Base Business process. Additionally, the role supports team growth through mentoring, coaching, and training colleagues, fostering collaboration, and maintaining relationships with local laboratories and stakeholders, while ensuring clear communication with eLIMS CoE leadership.

Requirements

Bachelor’s degree or equivalent education.
4 to 6 years of experience in a regulated industry such as pharmaceuticals, medical devices, or diagnostics.
Strong experience with LIMS/eLIMS systems and quality environments.
Solid understanding of cGMP principles, FDA regulations, ICH guidelines (Q8, Q9, Q10), and risk management.
Organized, able to manage multiple priorities, and comfortable working in a dynamic environment where flexibility is required.
Strong communication skills in English (minimum level B2).
Ability to effectively train and engage partners.
Strong customer focus, ability to build trustful relationships across global teams, and commitment to delivering high-quality results.
Understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices.
Comfortable using AI tools to enhance efficiency and productivity, including the ability to craft effective prompts to support day-to-day work.

Nice To Haves

Exposure to analytical testing, quality control, or IT is an advantage.

Responsibilities

Ensure high-quality data eLIMS configurations that enable efficient, compliant, and paperless laboratory workflows, including product release and Certificate of Analysis generation.
Design, maintain, and continuously improve data setups independently, ensuring alignment with current business processes and regulatory requirements.
Act as a bridge between business and IT, translating laboratory needs into robust system solutions.
Integrate laboratory instruments and applications into the eLIMS system.
Review and test system updates.
Create and maintain system documentation and standards.
Proactively find opportunities for process improvements and contribute to global harmonization and standardization efforts.
Deliver incoming requests in a timely and high-quality manner.
Develop a deep understanding of site-specific laboratory processes and master data requirements to ensure accurate and complete system configurations.
Lead or contribute to projects within QC Operations, such as continuous improvement initiatives related to the iLAB’s Base Business process.
Support the growth of the team by mentoring, coaching, and training colleagues, sharing expertise and fostering collaboration across regions.
Maintain close relationships with local laboratories and interested parties.
Ensure clear and effective communication with the eLIMS CoE leadership.