Senior Specialist LIMS

About the role

Lead and oversee LabVantage LIMS within the quality control laboratory; support enhancements and integrations.

Responsibilities

• Execute validation activities, ensuring compliance with GxP, data integrity, and CSV requirements.
• Maintain and update technical documentation, SOPs, and training materials.
• Provide support and training on LIMS including new system functionalities.
• Data Governance & Quality: Enforce data integrity standards, version control, and data accuracy across all laboratory processes. Ensure compliance with global corporate policies and regulatory standards (e.g., FDA 21 CFR Part 11, cGMP, ISO 17025).
• Cross-Functional Collaboration: Partner with lab subject matter experts (SMEs) to gather business requirements and map existing workflows to system capabilities.
• Own and update LIMS Standard Operating Procedures (SOPs).
• Build and maintain test definitions, sampling plans, specifications, and stability protocols in LIMS, in collaboration with QC SMEs.
• Support troubleshooting of data-related issues. Work with IT System Administrator to develop user requirements and test scripts for custom scripts, code, or automation tools to support LIMS integration with analytical instruments and other enterprise systems.
• Lead QA and QC to test system settings, user roles, and permissions.
• Support internal and external regulatory audits and inspections.
• Lead QC ongoing LIMS improvements and upgrades.

Requirements

• 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.

Preferred Experience

• Experience with LIMS as an end user and/or participation in an LIMS implementation.
• Software development experience with Java and/or Groovy.

Education, Experience, Certification and Licensures

• Required: Bachelor’s degree in Chemistry, Biology, Life Sciences or related field.
• Required: Minimum of 8 years of experience with pharma laboratory applications (LIMS, LES, ELN).
• Preferred: Strong experience with LabVantage LIMS master data building.
• Preferred: Understanding of GxP, data integrity, and computer system validation requirements.
• Preferred: Understanding of analytical testing and techniques.
• Preferred: Experience writing and updating technical documentation, SOPs, and training materials.
• Preferred: Experience with LIMS as an end user and/or participation in an LIMS implementation.
• Preferred: Software development experience with Java and/or Groovy.

Skills and Abilities

• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Ability to work in a fast-paced, regulated environment.
• Proactive mindset with the ability to anticipate and troubleshoot issues.
• Exceptional analytical thinking, strong attention to detail, and excellent verbal/written communication skills to bridge technical and scientific teams.

Supervisory Responsibilities

This position does not have supervisory responsibilities.

Physical Requirements

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Pay Range

$117,000 - $145,000