Equipment Validation Engineer

Equipment Validation Engineer

Job Summary

ASI is seeking an Equipment Validation Engineer to support oral solid dose pharmaceutical manufacturing operations in Tampa, Florida. The engineer will develop, execute, and evaluate qualification and validation activities demonstrating that facilities, manufacturing equipment, packaging equipment, and associated processes operate consistently and in compliance with cGMP requirements. The role includes authoring and executing IQ/OQ/PQ protocols and summary reports, supporting validation project planning, and coordinating with Engineering, Manufacturing, Quality, Maintenance, and external vendors to integrate validation activities into project and production schedules.

Relevant Equipment Experience

Experience with oral solid dose process and packaging equipment is desirable, including:

·  Fluid bed dryers

·  Granulators, including high-shear granulation equipment

·  Pharmaceutical mills, including cone and hammer mills

·  Bottle fillers

·  Blister fillers

·  Cappers

·  Labelers and barcode systems

·  Cartoners

·  Case packers

Responsibilities

·  Develop, execute, and analyze equipment and process validation projects supporting cGMP compliance.

·  Author and execute IQ, OQ, and PQ protocols and associated summary reports for manufacturing and packaging equipment.

·  Author or support change controls, SOPs, work instructions, and validation lifecycle documentation.

·  Provide technical support for deviations, CAPAs, investigations, and equipment or process changes.

·  Design and execute process and cleaning validation studies in accordance with site procedures and industry standards.

·  Support equipment startup, product changeovers, troubleshooting, and continuous improvement initiatives.

·  Coordinate with internal and external technical personnel to establish priorities, schedules, responsibilities, and practical validation approaches.

Requirements

Qualifications

·  Bachelor's degree in Engineering, Pharmacy, Science, or a related technical discipline.

·  Two or more years of experience in life sciences engineering, manufacturing, or validation.

·  At least one year of direct equipment qualification or validation experience.

·  Experience working in an FDA-regulated, cGMP-compliant manufacturing environment.

·  Experience with oral solid dose manufacturing or packaging equipment is strongly preferred.

·  Strong technical writing, collaboration, communication, and organizational skills.

·  Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.