Autoclave Specialist - Juncos - Mirus Consulting Group

Description

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.

Position Summary

We seek an experienced Autoclave Specialist with a strong background in autoclave systems and sterilization process validation to support a short‑term technical project. The selected candidate will play a key role in identifying tools requiring sterilization, conducting technical assessments of autoclave units, reviewing manufacturing SOPs, and executing validation activities for up to six autoclave loads over the next six months. This position will support the manufacturing area and may also assist with additional validation and execution activities as required. The Specialist will work collaboratively with cross‑functional partners, including Manufacturing, Quality, Maintenance, and Validation—to ensure regulatory compliance, process robustness, and alignment with the operational excellence standards.

Key Responsibilities

• Identify equipment and tools requiring sterilization within the manufacturing process.
• Conduct technical evaluations and performance assessments of autoclave systems.
• Review and interpret manufacturing SOPs to ensure alignment with sterilization requirements.
• Execute validation protocols for up to six autoclave loads within project timelines.
• Document validation results in accordance with regulatory and internal quality standards.
• Support broader validation and manufacturing operations as needed.
• Collaborate closely with Manufacturing, Quality Assurance, Maintenance, and Validation teams.
• Ensure adherence to cGMP, safety regulations, and corporate operational excellence practices.

Basic Qualifications

• Bachelor's degree completed (Engineering, Life Sciences, or related field preferred).
• Hands‑on experience with autoclave systems and sterilization process validation.
• Strong understanding of cGMPs, regulatory requirements, and validation documentation.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.

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