Validation Specialist

Job Details

Job Title:

Validation Specialist

Location:

Meriden, CT

Work Arrangement:
Hybrid

• 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

• 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

• 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

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.