Qualification and Validation Specialist

Qualification and Validation Specialist Advantage Technical $80.00•85.00 401(k) United States, Alabama, Birmingham Apr 23, 2026 Qualification & Validation Specialist (Contract•GMP/Aseptic)

Location:

Birmingham, AL Pay:

$80•85/hour

Duration:

6+ months (potential extension) We are seeking an experienced Qualification & Validation Specialist to support GMP equipment qualification and process scale-up in an aseptic pharmaceutical environment. This contract role focuses on commissioning, validation, and compliance for critical manufacturing systems. Key Responsibilities Develop and execute URS, SIC, and risk assessments (SRA) for equipment and facilities Lead Commissioning (COM), Installation (IQ), Operational (OQ), and Performance Qualification (PQ) activities Perform Computer System Validation (CSV) testing and documentation Support qualification of equipment including homogenizers, pump skids, CIP/SIP systems, WFI skids, pressure vessels, and temperature control units Identify, document, and resolve deviations during validation activities Ensure compliance with FDA, EU regulations, 21 CFR Part 11, and cGMP standards Collaborate cross-functionally to meet project timelines and validation milestones Qualifications Bachelor's degree in Engineering, Life Sciences, or related field (or equivalent experience) 3+ years of validation/qualification experience in aseptic pharmaceutical manufacturing Strong knowledge of GMP, regulatory compliance, and validation lifecycle Experience with Kaye Validator AVS, ValProbe, or similar systems preferred Excellent problem-solving, documentation, and communication skills Employee Benefits Medical, dental, vision, and pet insurance 401(k) Retirement Savings Plans Employee Assistance Program (EAP) Commuter/Parking Accounts People Perks Health Savings Account (HSA) AD&D Insurance Apply Now Click Apply Now to join a high-impact team supporting critical pharmaceutical manufacturing and validation projects. About Us Advantage Technical connects top•talent in technology, engineering, and technical fields with forward-looking companies. Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.