Description:
The LIMS System Administrator will implement LabVantage Laboratory Information Management System (LIMS) at the Catalent Greenville site. This position is responsible for developing, managing, and implementing the laboratory administration and compliance program for LIMS to ensure compliance with local and global regulatory agency requirements, internal company standards, and current industry practices. Additionally, the LIMS System Administrator will lead cross-functional teams comprised of laboratory, operations, EH&S, and Quality personnel at the Greenville facility and other Catalent sites to expand and improve the use of the LIMS system and to design and implement added-value applications within the LIMS environment.
Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Role:
- Perform and support system user access management, including domain user groups, routine access reviews, Windows folder access, and date/time synchronization, as well as resolving end‑user LIMS template and data entry issues.
- Identify operational improvement opportunities which LIMS can provide solutions
- Lead cross‑functional teams to develop site‑specific User Requirements in a harmonized format, and collaborate with IT, Quality, CSV, and global system owners to ensure LIMS complies with all applicable GxP, legal, and fiduciary policies and requirements.
- Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.
- Develop and revise site SOPs, including LIMS‑specific SOPs in collaboration with the vendor and discipline representatives; author, review, and approve LIMS‑related change controls; manage software updates, patches, and routine maintenance upgrades; and author or support validation documentation and system procedures for system qualification of LIMS and its integrations.
- Support training for end user and handoff for LIMS during new hire orientation (NEO) and implementation.
- Perform other duties as assigned.
The Candidate:
- Bachelor’s degree in Computer Science, Life Sciences, Engineering, other STEM-related field with at least 5 years of experience in the pharmaceutical industry or relevant laboratory experience in a related industry (OR) Associates degree in Computer Science, Life Sciences, Engineering, other STEM-related field with at least 7 years of experience in the pharmaceutical industry or relevant laboratory experience in a related industry.
- Experience with LIMS or a Material Management System (e.g., SLIM, IntelliLIMS, LabWare) is required.
- Knowledge of cGMP and other regulatory requirements relative to LIMS systems and software validation experience.
- LabVantage experience preferred.
- Hands-on experience with GROOVY or Java scripting to configure and optimize ELN/LES method workflows, including calculation logic and automated data handling preferred.
- Ability to work in a manufacturing environment. Ability to stand, walk, and sit for extended periods. Lift up to 25 lbs as needed.
Why You Should Work At Catalent:
- Spearhead exciting and innovative projects
- Fast-paced, dynamic environment
- High visibility to members at all levels of the organization
- 152 hours of PTO + 8 paid holidays