LIMS Master Data Coordinator

LIMS Master Data Coordinator

Position Summary

• The shift is Monday - Friday from 8 am - 4:30 pm.

• This position is 100% on-site at the Greenville site.

The LIMS Master Data Coordinator will be responsible for the creation and revision, as well as review and approval of master data within the LabVantage® Laboratory Information Management System (LIMS) implemented at the Catalent Greenville site. This position will be responsible for providing end-user support for all analytical groups as well as compliance to global Catalent and internal policies and procedures. Additionally, the LIMS Master Data Builder may be tasked to participate in a global process for general or Catalent Global applicable master data creation, revision, and review.

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:

• Support QC, AR&D departments in the build and/or revision, review and approval of master data, including but not limited to products, specifications, and methods in LIMS, per global and local LIMS procedure

• First-line support for end-user LIMS template and data entry issues

• Assist in the development, implementation, enhancement of the overall process for requesting, creating/revising, and reviewing of master data

• Assist in the development and implementation of a site process for the scheduling and status tracking of all site LIMS Master Data, including testing needs for Raw Material, Finished Goods, Stability, and other needed areas

• Work with the site LIMS Supervisor to maintain site and Catalent Global requirements of LIMS.

• Participate in the development and/or revision of site and/or Catalent Global Standard Operating Procedures (SOPs)

• Develop, validate, and maintain Electronic Laboratory Notebook (ELN) and Laboratory Execution System (LES) methods, including implementation of automated calculations using GROOVY-based scripting.

• Perform other duties as assigned.

The Candidate:

• Associate/bachelor’s degree in computer science, Life Sciences, Engineering, another STEM-related field is required.

• At least 2 years of experience in the pharmaceutical industry or relevant laboratory experience in a related industry is required. Knowledge of cGMP and other regulatory requirements relative to LIMS systems and software validation experience.

• Experience with LIMS or a Material Management System (e.g., SLIM, IntelliLIMS, LabWare) is required.

• 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

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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