Method Validation / Microbiologist Specialist

Method Validation / Microbiology Specialist

Duration: 8-Month Contract

Location: Onsite

Position Summary

Seeking an experienced professional with a strong background in Method Validation, Method Transfer, and Method Qualification within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will possess expertise in molecular biology and/or microbiology, strong project management capabilities, and the ability to effectively collaborate with cross-functional teams. Bilingual communication skills (English and Spanish) are required.

Key Responsibilities

• Lead and support method validation, transfer, and qualification activities.
• Provide technical guidance, data analysis, and issue resolution for laboratory assays and testing activities.
• Troubleshoot analytical and microbiological methods as needed.
• Ensure compliance with GMP, GLP, and safety requirements.
• Develop, revise, and review technical documents, procedures, protocols, and reports.
• Support laboratory investigations, audits, and regulatory inspections.
• Serve as a technical resource and provide training when required.
• Collaborate with internal and external stakeholders to drive project objectives and resolve technical challenges.

Qualifications

• Bachelor's degree in Biochemistry, Chemistry, Microbiology, or a related scientific discipline required.
• Master's degree with 2+ years of relevant experience, or Bachelor's degree with 4+ years of relevant experience.
• Hands-on experience in method validation, transfer, and qualification.
• Strong understanding of GMP regulations and pharmaceutical laboratory operations.
• Excellent technical writing, communication, and project management skills.
• Ability to work independently and lead cross-functional initiatives.
• Fluent in English and Spanish.