Qualification and Validation Specialist

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.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

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