Sterile Validation Engineer - Quality Assurance Focus

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

Job summary

GL Staffing is seeking a Validation Specialist / Validation Engineer to plan, execute, document, and maintain qualification and validation activities for sterile injectable pharmaceutical manufacturing. You will ensure facilities, equipment, utilities, and processes are qualified per FDA regulations, cGMP, and quality procedures.

You will collaborate across QA, Engineering, Production, QC, Microbiology, and other departments to ensure scientifically sound, compliant, and inspection‑ready

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, Engineering, or a related scientific or technical discipline.
• 5–10 years of relevant validation experience within pharmaceutical manufacturing.
• Hands‑on experience supporting sterile injectable pharmaceutical manufacturing is required.
• Demonstrated 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, including URS, DQ, IQ, OQ, PQ, requalification protocols and reports.
• Plan and execute qualification activities for equipment used in sterile injectable manufacturing, including isolators, RABS, and aseptic filling machines.
• Support qualification of utilities and systems (HVAC, PW, Clean Steam, compressed air, nitrogen).
• Execute/process validation activities, including PPQ and aseptic process simulations.

Skills

FDA cGMP regulations

21 CFR Parts 210 & 211

EU GMP Annex 1

Equipment Qualification

Process Validation

Quality Risk Management

Education

Bachelor's degree in Pharmacy, Chemistry, Biotechnology, Microbiology, Engineering, or related field

Job description

GL Staffing is seeking a Validation Specialist / Validation Engineer to plan, execute, document, and maintain qualification and validation activities for sterile injectable pharmaceutical manufacturing. You will ensure facilities, equipment, utilities, and processes are qualified per FDA regulations, cGMP, and quality procedures.

You will collaborate across QA, Engineering, Production, QC, Microbiology, and other departments to ensure scientifically sound, compliant, and inspection‑ready