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LIMS System Administrator

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 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 enduser LIMS template and data entry issues.

• Identify operational improvement opportunities which LIMS can provide solutions

• Lead crossfunctional teams to develop sitespecific 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 LIMSspecific SOPs in collaboration with the vendor and discipline representatives; author, review, and approve LIMSrelated 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

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.

Important Security Notice to U.S. Job Seekers:

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