Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• CQV Sample Management / LIMS Coordinator

Job Summary:

We are seeking an experienced CQV Sample Management / LIMS Coordinator to support cleaning characterization and sterilization execution activities in a GMP biologics manufacturing environment.

The individual will be responsible for coordinating sampling logistics, LIMS activities, labels, sample kits, laboratory interfaces, and results tracking to ensure samples and analytical results are available within required project timelines.

• Prepare and manage LIMS templates for project sampling activities.
• Coordinate sample labels, sample kits, containers, swabs, and other consumables.
• Verify availability of sampling supplies prior to manufacturing execution.
• Coordinate sample plans with CQV, Manufacturing, and QC Laboratories.
• Support sample collection, custody, documentation, and delivery to QC.
• Enter and track samples within LIMS.
• Monitor laboratory results against established service-level expectations.
• Maintain sample status trackers and communicate pending or delayed results.
• Support cleaning RFU and sterilization Conditional Release activities requiring analytical results.
• Ensure sampling documentation is complete, accurate, and GMP compliant.
• Support TOC and microbial surface-sampling activities when qualified.
• Coordinate closely with CQV Technical Leads during 24/7 execution periods.

Required Qualifications

• Experience supporting sample management within a GMP pharmaceutical, biotechnology, or laboratory environment.
• Experience with LIMS or comparable laboratory-information systems.
• Strong organizational and documentation skills.
• Knowledge of GMP sample traceability and chain-of-custody requirements.
• Ability to coordinate multiple samples and priorities during active manufacturing campaigns.

Preferred Qualifications

• Cleaning validation or CQV experience.
• Experience with TOC and microbial sampling.
• Previous experience with Amgen LIMS systems or manufacturing operations.
• Familiarity with Kneat, PI, Smartsheet, LMS, MAXIMO, or similar applications.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.