Data Scientist 3-USD

• Lead various analytical instruments qualifications with extensive experience on 21 CFR Part 11 compliance requirements.
• Act as owner of instrument asset from analytical team to collaborate with internal partners on appropriate instrumentation lifecycle management.
• Oversee instruments in the lab, which include calibration, PM, troubleshooting, new instrument induction and qualification implementation and documentation.
• Have a fundamental understanding of software 21 CFR Part 11 server IT requirements and hardware/software documentation requirements for QC purposes. Have hands-on experience to draft user requirements specification, performance qualification protocol and hardware/software validation protocol and report.
• Act as primary point of contact with EHS and QA teams to ensure lab readiness for walkthroughs and audits.
• Lead analytical lab relocation activities to ensure the instruments are handled and qualified properly pre and post move, * We are proposing the addition of a Sr QC instrument scientist role to support and strengthen the operational, compliance, and safety functions of the analytical laboratory. This role will focus on lab safety and instrument maintenance, instrument lifecycle management, and cGMP compliance readiness., A. Equipment Lifecycle Management
• Lead new equipment onboarding and qualification (IQ/OQ/PQ coordination)
• Manage instrument maintenance programs, including:
• Preventive maintenance scheduling
• Service contract management
• Vendor coordination
• Ensure instruments remain in a state of control and compliance

B. cGMP Compliance & Audit Readiness

• Maintain inspection readiness of the laboratory at all times
• Support internal and external audits (FDA, ISO, client audits)
• Ensure adherence to:
• SOPs
• Data integrity requirements
• Documentation practices

C. Software & Data Systems Qualification

• Oversee laboratory software validation/qualification (e.g., CDS, LIMS, instrument software)
• Ensure compliance with data integrity principles
• Support lifecycle management of computerized systems

D. Laboratory Relocation & Infrastructure Projects

• Support and coordinate lab relocation activities, including:
• Equipment move planning and qualification
• Utility and layout readiness
• Risk mitigation during transition
• Assist in new lab setup and infrastructure readiness

E. Inventory & Asset Management

• Oversee laboratory inventory systems, including:
• Chemicals, consumables, and standards
• Asset tracking and calibration schedules
• Ensure availability of critical materials while controlling costs

• Must be proficient with both analytical instrument hardware and software qualification requirements and activities for instruments like GPC-MALS, HPLC-ELSD, LC-MS, GC-FID/MS, FTIR etc.
• Extensive hands-on experience with analytical instrumentation operation, troubleshooting, maintenance and repair.
• Effective technical writing skills, including ability to write protocols, OOT investigations, and other technical reports and documents.
• Excellent interpersonal and communication skills with demonstrated ability to coordinate and prioritize activities to meet objectives on time and with a high level of quality.
• Extensive hands-on experience with QC LIMS implementation to connect analytical instruments with report exporting as well as centralized data management., Education Requirement: Typically requires a Bachelor’s degree in a technical discipline

Work Experience: 5-8 years of related experience