Sterile Validation Specialist — GMP & Compliance

GL Staffing; Boca Raton (FL); On-site; USD 75,000 - 95,000; Full time

Job summary

GL Staffing in Boca Raton, FL seeks a Validation Specialist/Engineer to plan, execute, document, and maintain qualification activities for sterile injectable manufacturing operations, ensuring compliance with FDA regulations, cGMP, and industry standards.

The role collaborates with Quality Assurance, Engineering, Production, QC, Microbiology, and other departments to keep validation scientifically sound, properly documented, and inspection-ready, with a focus on equipment, utilities, cleaning

Qualifications

• 5–10 years of relevant validation experience in pharmaceutical manufacturing.
• Hands-on experience supporting sterile injectable pharmaceutical manufacturing is required.
• Experience with equipment qualification, utility qualification, process validation, and/or cleaning validation.
• Experience working in regulated pharmaceutical manufacturing environments with strong documentation and compliance requirements.

Responsibilities

• Prepare, review, execute, and maintain validation and qualification documentation (URS, DQ, IQ, OQ, PQ).
• Plan and execute qualification activities for equipment used in sterile injectable manufacturing (Vial washers, Autoclaves, Filling lines).
• Support validation of HVAC, PW, Clean Steam, Compressed Air, and Nitrogen utilities.
• Execute process validation activities and aseptic process simulations.
• Coordinate cleaning validation and verification activities.
• Review deviations and assist CAPAs and change controls.

Skills

Validation expertise

Sterile manufacturing experience

Documentation & QA compliance

Regulatory knowledge (FDA/cGMP)

Education

Bachelor's degree in Pharmacy/Engineering/Cooded sciences

Tools

CSV software

Job description

GL Staffing in Boca Raton, FL seeks a Validation Specialist/Engineer to plan, execute, document, and maintain qualification activities for sterile injectable manufacturing operations, ensuring compliance with FDA regulations, cGMP, and industry standards.

The role collaborates with Quality Assurance, Engineering, Production, QC, Microbiology, and other departments to keep validation scientifically sound, properly documented, and inspection-ready, with a focus on equipment, utilities, cleaning