Senior Specialist LIMS

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

Senior Specialist LIMS in Rensselaer, NY

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.

We proudly offer

• 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
• And more!

Summary

This role will be responsible for partnering with LIMS subject matter experts to ensure the implementation of LIMS at the Rensselaer, New York site is consistent with the program across the global network.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Essential job duties

• In collaboration with the Manager of QC Lab Remediation, lead and oversee LIMS within the quality control laboratory; support enhancements and integrations
• Lead and oversee LabVantage LIMS within the quality control laboratory; support enhancements and integrations.
• Validation & Compliance:Execute validation activities, ensuring compliance with GxP, data integrity, and CSV requirements.
• Documentation & SOPs: Maintain and update technical documentation, SOPs, and training materials.
• User Training: 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.
• Documentation: 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.

Education, experience, certification and licensures Required

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

Knowledge, 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all j