Test Methods Transfer & Validation Specialist - Microbiology

Test Methods Transfer & Validation Specialist - Microbiology is responsible for planning, executing, and documenting microbiological method transfers, validations, verifications, and continuous improvement initiatives in compliance with applicable regulatory requirements and quality standards. This role ensures that microbiological methods are robust, reproducible, and fit for their intended use across internal and external laboratories.

Key Responsibilities

• Lead and support test method transfer projects between laboratories, manufacturing sites, or functional areas.
• Develop and execute validation protocols, transfer plans, and supporting technical documentation.
• Perform method validation, verification, and transfer studies in accordance with internal procedures and regulatory requirements.
• Analyze and interpret data to assess method accuracy, precision, repeatability, reproducibility, and robustness.
• Investigate out-of-specification (OOS) results, deviations, nonconformances, and method-related issues.
• Prepare technical reports, summaries, and presentations to communicate study outcomes and recommendations.
• Collaborate with Quality, Engineering, Manufacturing, Research & Development, Regulatory Affairs, and Laboratory Operations teams.
• Ensure compliance with GMP, GLP, ISO standards, FDA regulations, and company quality system requirements.
• Support internal and external audits by providing documentation and technical expertise.
• Identify opportunities for process improvements and implement best practices related to method transfer and validation activities.

Requirements

• Bachelor’s or Master’s degree in Microbiology, Biology
• Minimum of five (5) years of experience in a regulated industry (pharmaceutical, biotechnology, or medical device) within a Microbiology, Quality Control, or Analytical Development laboratory.
• Hands-on experience conducting microbiological method transfers, validations, and verifications.
• Strong knowledge of cGMP, FDA, USP, EP, and other applicable regulatory and compendial requirements.
• Experience in method validation, method transfer, analytical testing, quality control, or laboratory operations within the pharmaceutical, biotechnology, medical device, or related regulated industries.
• Experience working in FDA, GMP, GLP, ISO, or other regulated environments.
• Familiarity with protocol development, technical documentation, deviation management, and change control processes.
• Bilingual in Spanish and English (written and spoken)