Technical Lead II – GxP Validation
Location: Fort Worth, Texas — 100% onsite, 5 days/week
Main Responsibilities:
Perform microbiological validations: Bioburden, Endotoxin, Sterility & PET.Support QC Microbiology laboratory operations.
Conduct equipment qualifications and support Media Fill/Reads.
Identify quality issues, troubleshoot, and implement corrective actions/improvements.
Prepare protocols, reports, and SOPs as required.
Follow GxP/GDP and pharmaceutical regulatory requirements.
Collaborate with Production, Maintenance, Warehouse, and other departments.
Support training, scheduling, supplies, and overall lab workflow.
Key Qualifications:
Bachelor's degree or equivalent relevant experience.
Strong knowledge of pharmaceutical/GxP regulatory requirements.
Excellent written and verbal communication.
Detail-oriented, proactive, and able to manage multiple projects independently.
Comfortable working overtime/flexible hours when required.
