Senior LIMS Specialist — QC Lab & LabVantage Validation

Curia Aalborg ApS; New York (NY); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Generous benefit options

Paid training

Career advancement opportunities

Education reimbursement

401K with match

Learning platform

Job summary

Curia is seeking a Senior Specialist LIMS to lead the implementation of LabVantage LIMS at the Rensselaer, NY site, aligning with our global program. You will drive validation, documentation, and data governance to ensure compliance with FDA 21 CFR Part 11, cGMP, and ISO 17025 across QC activities.

The role requires extensive experience with pharma laboratory apps, strong analytical skills, and the ability to collaborate across SMEs and IT to enable system integrations and training.

Qualifications

• Bachelor's degree in Chemistry, Biology, Life Sciences or related field.
• Minimum of 8 years of experience with pharma laboratory applications (LIMS, LES, ELN).
• Strong experience with LabVantage LIMS master data building.
• Understanding of GxP, data integrity, and computer system validation requirements.
• Understanding of analytical testing and techniques.
• Experience writing and updating technical documentation, SOPs, and training materials.

Responsibilities

• Lead and oversee LIMS within the QC laboratory; support enhancements and integrations.
• Validation & Compliance: execute validation activities per GxP, data integrity, and CSV requirements.
• Documentation & SOPs: maintain and update technical docs, SOPs, and training materials.
• User Training: provide support and training on LIMS functionalities.
• Data Governance & Quality: enforce data integrity standards and version control across processes.

Skills

Analytical thinking

Communication

Regulated environment

Problem solving

Team collaboration

Education

Bachelor's degree in Chemistry or Life Sciences

Tools

LabVantage LIMS

SOPs

CSV

Job description

Curia is seeking a Senior Specialist LIMS to lead the implementation of LabVantage LIMS at the Rensselaer, NY site, aligning with our global program. You will drive validation, documentation, and data governance to ensure compliance with FDA 21 CFR Part 11, cGMP, and ISO 17025 across QC activities.

The role requires extensive experience with pharma laboratory apps, strong analytical skills, and the ability to collaborate across SMEs and IT to enable system integrations and training.