GMP Validation Technician - Sterile Drug Manufacturing

Fagron; Wichita (KS); On-site; USD 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Job summary

Fagron US seeks a Validation Technician to execute and document calibration, qualification, and validation activities in a 503B outsourcing setting. The role ensures equipment, utilities, and clean environments meet FDA and cGMP data integrity standards.

You will perform IQ/OQ/PQ, support risk assessments and periodic reviews, manage data systems, and keep meticulous documentation to maintain compliance across operations and investigations.

Qualifications

• AS degree in technical/engineering/pharma or equivalent experience.
• 2–4 years in pharmaceutical or sterile manufacturing; 503B preferred.
• Knowledge of cGMP, validation principles, cleanroom operations, and aseptic processing.
• Familiarity with USP, ISPE, PDA, and FDA sterile compounding guidance.
• Strong documentation skills in regulated environments.
• Effective communication and cross-functional collaboration.

Responsibilities

• Perform calibration, qualification (IQ/OQ/PQ), and requalification of manufacturing equipment and instruments.
• Execute approved validation protocols and generate compliant final reports.
• Support validation lifecycle activities, including risk assessments and periodic reviews.
• Operate and maintain validation data acquisition systems (e.g., Kaye AVS).
• Document activities according to ALCOA+ data integrity principles.
• Maintain calibration/validation databases with NIST traceability.
• Coordinate external contractors for cleanroom certification.
• Troubleshoot and perform minor repairs on instruments and equipment.
• Ensure compliance with 21 CFR Parts 210/211 and internal quality systems.
• Support investigations with technical data and root cause analysis.

Skills

Documentation

Cross-functional collaboration

Regulatory compliance

Communication skills

Aseptic processing

Education

AS degree in technical/engineering/pharma

Tools

Kaye AVS

Job description

Fagron US seeks a Validation Technician to execute and document calibration, qualification, and validation activities in a 503B outsourcing setting. The role ensures equipment, utilities, and clean environments meet FDA and cGMP data integrity standards.

You will perform IQ/OQ/PQ, support risk assessments and periodic reviews, manage data systems, and keep meticulous documentation to maintain compliance across operations and investigations.