Validation Specialist

Job Details

Job Title: Validation Specialist

Location: Meriden, CT

Work Arrangement: Hybrid

About the Role

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.

Key Responsibilities

Validation Execution

• 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

Equipment, Utility & Cleaning Validation

• 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

Computerized Systems Validation (CSV)

• 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

Spreadsheet & Barcode Systems

• Verify spreadsheet functionality, formulas, and documentation controls
• Support barcode system testing, verification, user acceptance testing (UAT), and change implementation activities

GMP Compliance & Quality Support

• 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

Skills

Technical Skills

• 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.

Core Competencies

• 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

Job Requirements

• 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

About Caldic

At Caldic, we're a global leader in distribution solutions, serving diverse markets across the world. Joining us means becoming part of an entrepreneurial, collaborative, and innovation-driven team.

We offer:

• Competitive benefits including medical, dental, vision, life, legal, 401(k) with company contributions, paid time off and more
• An inclusive, diverse, and dynamic work environment
• The chance to shape the future of specialty ingredient solutions across industries like food, pharma, personal care, and more

We operate in 43 countries around the world. Our innovative solutions are tailored to meet the needs of industries such as food, pharma, personal care, and industrial markets, ensuring sustainable success for all stakeholders. To learn more, visit:

Ready to Join Us?

If you're ready to take your career to the next level and join a global leader, apply now at Caldic!

Equal Opportunity Employer

Caldic celebrates diversity and is committed to fostering an inclusive work environment. We do not discriminate on the basis of race, religion, gender, or any other characteristic.

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