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Validation Specialist-Methods Transfer
Job Location:
Job Location:
Juncos - Puerto Rico
Monthly Salary:
Not provided by the employer
Monthly Salary:
Experience Required:
5years
Experience Required:
Posted:
16 October 2026 (Yesterday)
Posted:
Application Deadline:
13 January 2027
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
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
- Bachelors or Masters 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).
Required Skills:
Bachelor in Microbiology/Biology At least five years experience with laboratory equipment qualifications Method transfer experience Bilingual (Spanish/English) Technical writing
Required Education:
BS Microbiology/Biology
