Qualification and Validation Specialist
Advantage Technical, Birmingham, AL, United States
Overview
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.
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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.
#J-18808-Ljbffr