JT589 - RELIABILITY ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team.

In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities : Manufacturing Equipment ownership at CMMS system ( Work orders approval, closing, PM strategy, spare parts' definition / accuracy / updates ), reliability and change control assessments and requirements.

Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.

Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization.

Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.

Lead the implementation of equipment improvements projects.

SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.

Support equipment troubleshooting within the functional area or in the scope of technical expertise.

Support deviation process and define, implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization.

Qualifications :   Bachelor's degree in Engineering 2 years of Engineering experience Experience with equipment and / or process troubleshooting in a regulated environment Familiarity with validation processes Familiarity with documentation in a highly regulated environment Able to develop solutions to routine technical problems of limited scope Knowledge of pharmaceutical / biotech processes and GMP production operations Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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