What are the responsibilities and job description for the Validation Specialist position at Unicon Pharma Inc?
Multiple Validation Engineer: W-2
Analytical Instrument Validation Engineer Responsibilities:
- Conduct full qualification packages, including IQ, OQ, and PQ testing (equipment validation only, not method validation).
- Perform data integrity assessments per 21 CFR Part 11 and ERES compliance.
- Experience with plate readers, plate particle analysis, chromatography, and TOC analysis.
- Proficient with Data Guard, Data Pro, Moda, Apex, Endoscan, and Empower 3 software.
- Responsible for reviewing, approving, and creating administrative documents while maintaining validation plans.
Equipment Validation Engineer Responsibilities:
- Specializing in validation of chambers, freezers, incubators, and other temperature-controlled equipment.
- Conduct temperature mapping and mapping studies.
- Support integrations with data historians.
- Oversee qualification activities, including review, approval, and execution of protocols.
