Senior Specialist LIMS

About the role

Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life‑saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives. This position is based in Albuquerque, NM.

Responsibilities

• Serve as site administrator and Quality Control business owner for the LabVantage LIMS platform.
• Manage system configuration, master data, test methods, specifications, sampling plans, stability protocols, instrument mappings and workflow definitions.
• Administer LIMS user accounts, roles, permissions and periodic access reviews in accordance with company procedures and data integrity requirements.
• Monitor system performance and coordinate resolution of system issues with IT and vendors.
• Act as primary site liaison for vendor support, upgrades, system enhancements and troubleshooting activities.
• Coordinate and lead validation activities associated with LIMS implementation, upgrades, enhancements and maintenance.
• Develop and maintain user requirements, risk assessments, test protocols, traceability matrices, validation reports and supporting documentation.
• Ensure compliance with current Good Manufacturing Practices (cGMP, FDA 21 CFR Part 11, data integrity expectations, and company procedures.
• Support periodic reviews and system lifecycle management activities.
• Serve as Quality Control representative and business owner for LIMS‑related change controls.
• Assess proposed system changes for regulatory, business, validation and operational impact.
• Collaborate with stakeholders to identify, prioritize and implement system improvements.
• Support deployment of new functionality, integrations and automation initiatives.
• Provide technical support and guidance for laboratory personnel utilizing LIMS.
• Develop and maintain training materials, work instructions and operating procedures.
• Deliver user training related to new system functionality and process changes.
• Investigate and resolve system‑related issues impacting laboratory operations.
• Establish and maintain standards for LIMS master data creation, review, approval and maintenance.
• Ensure data accuracy, version control, traceability and compliance with data governance requirements.
• Support implementation of new products, methods, specifications and laboratory workflows within the system.
• Maintain data mapping and associated technical documentation.
• Partner with QC, QA, Manufacturing, Stability, Regulatory Affairs and Information Technology teams to understand business requirements and optimize laboratory workflows.
• Coordinate testing activities associated with new functionality, upgrades and integrations.
• Participate in project teams supporting digital laboratory initiatives.
• Support internal audits, customer audits and regulatory inspections involving laboratory computerized systems.
• Provide system documentation, records, validation packages and subject matter expertise during inspections.
• Support investigations and corrective actions related to LIMS, data integrity and laboratory systems.

Requirements

• Bachelor’s degree in Chemistry, Biology, Life Sciences, Engineering, Computer Science or related field.
• Minimum 5 years of experience in a GMP‑regulated pharmaceutical, biotechnology or life sciences environment.
• Minimum of 2 years of experience supporting LIMS administration, configuration, implementation or system ownership.
• Experience with computerized laboratory systems and business processes.
• Knowledge of cGMP regulations, FDA 21 CFR Part 11 requirements, data integrity principles, and computer system validation requirements.
• Understanding