LIMS Project Leader III; IT

Job Title: LIMS Project Leader III
Location: Swiftwater, PA (3 days on-site hybrid with potential for fully remote)
Contract: 6-months (with possibility of extension)
Schedule: Monday - Friday; 8 AM - 4:30 PM
Pay Rate Max: $90 per hour

Sanofi's contingent workforce program, FLEXT Direct, is seeking a LIMS Project Leader III for a 6-month contract. Are you a detail-oriented professional with a passion for laboratory informatics and quality operations? We are seeking a highly skilled and motivated individual to join our Quality Operations team at the Swiftwater site. In this critical role, you will be responsible for the maintenance and continuous improvement of our Laboratory Information Management System (LIMS), playing a pivotal part in ensuring the seamless operation of our laboratory environment.

You will collaborate with cross-functional teams, provide technical expertise, and drive system evolution to support our mission of delivering high-quality pharmaceutical products. This is an exciting opportunity to make a meaningful impact in a dynamic and fast-paced environment while working at the forefront of laboratory informatics.

• Ensure site on-time implementation of OneLIMS Raw Materials activities through support of master data requirements definition, functional design, master data configuration and data migration, site system validation, SOP revisions, and development of end-user training
• Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability, and R&D operations
• Support business and Global IS LIMS Administrator in the creation, validation, and maintenance of reports, calculations, and queries
• Provide first level diagnostic of incidents and support business users, IS LIMS Administrator, and Support Center in the management and timely resolution of technical issues
• Manage the master data management process, including updating specifications and analysis, and supporting the approval and verification process
• Manage Global System updates and changes, which may include new modules and workflow changes
• Configure and maintain instrument interfaces to laboratory equipment
• Support the business and IS LIMS Administrator in the definition, approval, and validation of new business requirements
• Ensure that the LIMS complies with all relevant regulatory standards
• Support the business in the creation and updating of training materials as changes to the system occur
• Support the creation of new master data for new Lab Ware System build for Raw Materials into ONE LIMS Global System
• Translate data from existing electronic systems for use in mass upload tools and configuration

• Working knowledge of aseptic processes, biology, chemistry, and life sciences
• Strong supervisory and leadership skills
• Knowledge of cGMPs and regulatory requirements
• Strong analytical and balanced decision-making skills
• Excellent written and verbal communication skills
• Ability to lead and participate in cross-functional teams
• Familiarity with 21
  
  CFR Part 11 data integrity best practices in a pharmaceutical environment
• Experience with SQL and database structures (preferred)
• Strong project management skills (preferred)

• 3+ years of experience in the use and administration of a Lab Ware LIMS, including LIMS Basic
• Strong working knowledge of laboratory processes, including cGMPs in a pharmaceutical environment
• Experience in system testing, validation, and master data management
• Experience or familiarity with the laboratory environment
• Experience with other systems such as laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, Lab X, or SAP (preferred)
• Experience migrating master data from Lab Ware V6 to Lab Ware V8 (preferred)

• Bachelor's degree in a scientific discipline such as biology, chemistry, life sciences, or a related field
• Knowledge of cGMP regulations and 21
  
  CFR Part 11 compliance requirements

This is a truly exciting opportunity for a driven and knowledgeable professional to take on a high-impact role within a leading pharmaceutical organization. You will have the chance to shape the future of laboratory informatics, work alongside talented and dedicated colleagues, and contribute to the development of life-saving products. If you are ready to bring your expertise to a role that offers both challenge and reward, we encourage you to apply and become a key part of our innovative and growing team.