Automated Systems, Inc. | Contract, 6 months
Equipment Validation Engineer
Tampa, United States | Posted on 07/24/2026
- Industry Pharma/Biotech/Clinical Research
- State/Province Florida
- City Tampa
- Country United States
Job Description
Equipment Validation Engineer
Location: Tampa, FL - onsite
Contract: 6 months
Job Summary
ASI is seeking an EquipmentValidation Engineer to support oral solid dose pharmaceuticalmanufacturing 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 operateconsistently and in compliance with cGMP requirements. The role includesauthoring and executing IQ/OQ/PQ protocols and summary reports, supportingvalidation project planning, and coordinating with Engineering, Manufacturing,Quality, Maintenance, and external vendors to integrate validation activitiesinto project and production schedules.
Relevant Equipment Experience
Experience with oral solid doseprocess and packaging equipment is desirable, including:
- Pharmaceutical mills, including cone and hammer mills
- Bottle fillers
- Labelers and barcode systems
Responsibilities
- Develop, execute, and analyze equipment and processvalidation projects supporting cGMP compliance.
- Author and execute IQ, OQ, and PQ protocols andassociated summary reports for manufacturing and packaging equipment.
- Author or support change controls, SOPs, workinstructions, and validation lifecycle documentation.
- Provide technical support for deviations, CAPAs,investigations, and equipment or process changes.
- Design and execute process and cleaning validationstudies in accordance with site procedures and industry standards.
- Support equipment startup, product changeovers,troubleshooting, and continuous improvement initiatives.
- Coordinate with internal and external technicalpersonnel to establish priorities, schedules, responsibilities, and practicalvalidation approaches.
Requirements
Qualifications
- Bachelor's degree in Engineering, Pharmacy, Science,or a related technical discipline.
- Two or more years of experience in life sciencesengineering, manufacturing, or validation.
- At least one year of direct equipment qualification orvalidation experience.
- Experience working in an FDA-regulated, cGMP-compliantmanufacturing environment.
- Experience with oral solid dose manufacturing orpackaging equipment is strongly preferred.
- Strong technical writing, collaboration,communication, and organizational skills.
- Proficiency with Microsoft Word, Excel, PowerPoint,and Outlook.