Description

Validate design, implementation, and documentation for manufacturing equipment, utility systems, and automation processes.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) and construct summary reports.
• Write and update SOPs to improve efficiency and compliance.
• Perform cleaning verification via swab/rinse sampling for active ingredients and contaminants.
• Review and develop URS, FRS, and DS documentation in conformance with FDA regulations.
• Manage deviations, risk assessments, and change control processes.

Required Skills

• 5+ years of experience in validation engineering.
• Bachelor’s Degree in Biomedical Engineering, Biotechnology, or a related field.
• Hands-on experience with IQ, OQ, and PQ protocols.
• Proficiency in writing and implementing SOPs.
• Experience with CIP and COP systems.
• Knowledge of FRS and design specification development.
• Experience with Trackwise and Crystal Reports for status reporting and metrics.
• Understanding of 21 CFR Part 11, Annex 11, and Data Integrity requirements.

Key Skills

Education

Bachelor’s Degree