Methods Transfer & Validation Specialist - Microbiology
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Key details
- Location
- Aibonito, PR, United States
- Work style
- Onsite
- Level
- Senior
- Job type
- Contract
- Experience
- 5–8 yrs
- Function
- Science & Research
- Focus area
- other
- Posted
- 3d ago
Skills
gmpmethod validationprocess optimizationquality controlregulatory auditstechnical documentationtechnical writing
About the role
The 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
- Plan, coordinate, and execute microbiological method transfers between laboratories, ensuring successful implementation and compliance with predefined acceptance criteria.
- Perform method validation and verification activities in accordance with regulatory requirements, pharmacopoeial standards, and internal procedures.
- Develop and execute protocols for microbiological testing, including bioburden, sterility, bacterial endotoxins, environmental monitoring, and microbial identification methods.
- Analyze and interpret microbiological data, investigate laboratory deviations, and support root cause investigations and corrective/preventive actions (CAPAs).
- Prepare, review, and maintain technical documentation, including validation protocols, reports, standard operating procedures (SOPs), and testing procedures.
- Collaborate with Quality, Manufacturing, Validation, and Regulatory Affairs teams to ensure microbiological compliance throughout the product lifecycle.
- Support internal, customer, and regulatory audits by providing technical expertise and documentation evidence.
- Identify opportunities for process optimization, method improvements, and continuous quality enhancement within the microbiology laboratory.
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 with microbiological testing techniques, including sterility testing, bioburden testing, bacterial endotoxin testing, environmental monitoring, microbial identification, and microbial recovery studies.
- Strong technical writing and documentation skills.
- Excellent analytical, problem-solving, and organizational abilities.
- Bilingual in Spanish and English (written and spoken).
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