LIMS Validation Specialist

Experience:

About the Role:

We’re looking for someone who knows LIMS inside out and can take full ownership of its validation activities. If you’ve worked closely with lab systems, understand compliance requirements, and are comfortable guiding teams and interacting with clients, this role will fit you well.

Key Responsibilities:

• Own end-to-end validation of the LIMS application, including instrument integration and lab workflows.

• Prepare and review CSV protocols for various LIMS workflows.

• Collaborate with cross-functional teams and ensure smooth execution of validation tasks.

• Work directly with customers to clarify requirements, provide updates, and flag challenges when needed.

• Support project documentation and maintain compliance with QMS processes.

• Ensure all activities align with data integrity expectations, including ALCOA+ principles.

Required Skills and Experience

• Strong functional understanding of lab systems, equipment operations, and lab workflows.

• Solid experience in LIMS operations or validation projects.

• Hands-on knowledge of 21 CFR Part 11 and Annex 11 regulatory requirements.

• Clear, confident communication skills for both client and internal interactions.

• Experience working in a matrix or cross-functional environment.

• Project management exposure or QMS experience is an added advantage.