Main Responsibilities:

• Support EO sterilization and microbiological testing activities within a regulated manufacturing environment.
• Perform microbiological analyses on raw materials, in-process materials, release samples, and stability samples.
• Prepare, clean, disinfect, sterilize, store, and handle laboratory instruments, materials, products, and supplies.
• Support sterilization validations including protocol execution, documentation, and report preparation.
• Interpret and evaluate analytical results against established specifications and support corrective action activities when necessary.
• Assist in developing, validating, and implementing controlled environment methods and laboratory procedures.
• Perform qualitative and quantitative testing using standard laboratory equipment and automated instrumentation.
• Support methodology transfer activities from R&D into manufacturing or laboratory operations.
• Maintain accurate technical documentation, validation records, protocols, and reports in compliance with GDP requirements.
• Collaborate with Manufacturing, Quality, Engineering, Regulatory, and R&D teams to support sterilization and microbiological initiatives.
• Participate in continuous improvement activities related to sterilization, laboratory operations, and microbiological processes.
• Follow FDA regulations, ISO standards, and company quality procedures.

*Other duties may be assigned.*
 

Requirements

Education

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemistry, Biomedical Sciences, or related scientific discipline.

• Entry-level candidates are acceptable.
• Equivalent foreign degrees must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Required Skills & Qualifications

• Knowledge of EO sterilization processes.
• Familiarity with FDA regulations, ISO 11135, ISO 11737, and related sterilization and microbiological standards.
• Strong technical documentation and report-writing skills.
• Ability to support sterilization validations, protocols, and testing activities.
• Strong analytical and problem-solving skills.
• Ability to communicate findings clearly and collaborate effectively with cross-functional teams including Manufacturing, Quality, Regulatory, and R&D.
• Fully bilingual (English and Spanish).

Preferred Qualifications

• Experience in regulated manufacturing, pharmaceutical, biotechnology, or medical device industries.

• Experience with TrackWise or similar quality management systems.
• Knowledge of environmental monitoring and controlled environments.
• Exposure to validation and laboratory quality systems.

Technical Skills

• Microsoft Office Suite
• TrackWise
• Agile environment exposure
• Technical documentation
• Sterilization validation support
• Microbiological testing techniques
• Controlled environment practices

Work Methodology:

• 100% on site job
• Full time job
• 1 year of first contract term with expectation of continuity based on performance and budget
• Location: Salinas, PR
• Administrative shift
• Type of industry: Medical devices