Validation Specialist

caldicbv•Meriden, IL

1d•Hybrid

About The Position

At BrandNu, a Caldic Company, our strength lies in inspiring solutions to address our customer’s challenges in the pharmaceutical market. Our parent, Caldic, a distribution solutions partner of specialty chemicals and ingredients unlocking value in life science and material sciences. We drive innovation in the food personal care, pharma and industrial markets. As a key contributor to quality and compliance initiatives, the Validation Specialist is responsible for executing validation and qualification programs that support pharmaceutical manufacturing and GMP-regulated systems. This role will lead day-to-day validation activities for equipment, cleaning processes, computerized systems, spreadsheets, barcode technologies, utilities, and other critical manufacturing systems. The ideal candidate combines technical expertise with a proactive, solutions-oriented mindset, ensuring validation projects are completed efficiently, accurately, and in accordance with regulatory expectations. Success in this role requires strong documentation skills, independent project ownership, and the ability to thrive in a fast-paced, highly regulated environment. This is an excellent opportunity for a validation professional who enjoys solving technical challenges, driving compliance, and making a direct impact on pharmaceutical operations and product quality.

Requirements

Proficiency in FDA cGMP regulations, GDP documentation practices, and basic data integrity principles
Proficiency in Microsoft Excel and Word
Ability to follow protocols and execute detailed testing activities accurately
Strong attention to detail
Technical writing and documentation skills
Ability to manage multiple assignments
Self-motivated and execution-oriented
Strong organizational and communication skills
Ability to work both collaboratively within a team and independently with minimal supervision
Bachelor's degree or equivalent experience in Engineering, Life Sciences, Pharmaceutical Sciences or related technical discipline
2 - 5 years experience in GMP-regulated industries preferred
Exposure to pharmaceutical, biotechnology, medical device or regulated manufacturing environments

Responsibilities

Execute validation lifecycle activities, including IQ/OQ/PQ protocols, testing, data collection, traceability documentation, and summary reports
Support deviation investigations, discrepancy resolution, and document updates
Perform qualification activities for manufacturing equipment, packaging systems, laboratory instruments, utilities, temperature-controlled units, and other support equipment
Execute cleaning validation protocols, sampling activities, and verification studies
Coordinate testing with Manufacturing and Engineering teams and maintain validation data packages
Execute validation testing for GMP computerized systems, including laboratory, quality, barcode, spreadsheet, and manufacturing support applications
Support data integrity and 21 CFR Part 11 compliance requirements
Maintain validation documentation and test evidence
Verify spreadsheet functionality, formulas, and documentation controls
Support barcode system testing, verification, user acceptance testing (UAT), and change implementation activities
Support change controls, CAPAs, deviations, periodic reviews, SOP revisions, and other Quality Unit activities
Maintain inspection-ready documentation and ensure compliance with FDA cGMP requirements and internal procedures