Senior Specialist LIMS

Curia • Rensselaer, NY

5d • Onsite

About The Position

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.

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.
• 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.
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

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

Responsibilities

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

Benefits

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform

What This Job Offers

• Job Type: Full-time
• Career Level: Senior