Validation Technician

About the role

The Validation Technician executes and documents calibration, qualification, and validation activities that support sterile drug manufacturing within a 503B outsourcing facility. This role ensures equipment, utilities, and controlled environments operate in compliance with FDA, cGMP, and data integrity requirements.

Responsibilities

• Perform calibration, qualification (IQ/OQ/PQ), and routine requalification of manufacturing equipment, utilities, and critical 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 all activities according to ALCOA+ data integrity principles.
• Maintain calibration/validation databases with NIST traceability.
• Cook up and 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.

Requirements

• AS degree in a technical/engineering/pharma discipline or equivalent experience.
• 2–4 years experience 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 ability to collaborate cross-functionally.

Qualifications

• AS degree in a technical/engineering/pharma discipline or equivalent experience.
• 2–4 years experience 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 ability to collaborate cross-functionally.

Skills

• Technical proficiency in sterile manufacturing processes.
• Experience with validation and compliance procedures.
• Strong attention to detail and data integrity.
• Ability to troubleshoot and perform basic repairs.
• Excellent communication and collaboration skills.

Benefits

• Competitive salary.
• Comprehensive benefits package.
• Performance-based compensation.
• Opportunity to work for an expanding, international, professional pharmaceutical company.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with standard business hours.