Manufacturing Engineer

Kedrion Biopharma • Melville, NY • 1h ago

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

Power the Future of Manufacturing Reliability.

Join our team as a Manufacturing Technical Engineer and play a key role in improving equipment performance, optimizing maintenance strategies, and strengthening the reliability of critical production systems. In this role, you will drive root-cause analysis initiatives, develop preventive maintenance plans, and support the successful execution of engineering projects-all while contributing to a culture committed to safety, quality, and operational excellence.

What You'll Do

Perform equipment and system reliability analysis, including RCA and FMEA.

Create, develop, and manage preventive maintenance plans and spare-parts strategies for process equipment.

Provide hands-on field engineering support for manufacturing operations.

Support project implementation activities and validation protocols (IQ, OQ, PQ, IOV).

Develop, revise, and implement SOPs related to engineering and maintenance.

Apply risk-management strategies for capital projects and identify mitigation actions.

Partner closely with maintenance teams to align preventive maintenance activities with reliability goals.

Analyze equipment performance data to identify trends and opportunities for improvement.

Collaborate across departments to implement corrective and preventive actions based on RCA findings.

Ensure compliance with applicable regulations and industry standards, including cGMP requirements.

Prepare and deliver regular performance and reliability reports to management.

Support operational continuity through effective communication and teamwork.

Complete assigned tasks within expected timelines and participate in required training and meetings.

Qualifications

Bachelor's degree in engineering or a related field.

Minimum of 5 years of experience in a manufacturing environment; experience with tanks, pumps, and piping systems is a plus.

Experience supporting equipment installation and project management.

Strong understanding of maintenance principles, reliability engineering, and equipment performance.

Strong analytical and problem-solving skills with an inclusive, collaborative communication style.

Familiarity with cGMP standards and applicable regulatory requirements.

Ability to work within a 24/7 industrial facility, including exposure to varying temperatures and elevated work areas.

Willingness to work weekends and holidays as needed based on operating conditions.

Ability to travel up to 10% to company locations, meetings, and events, including overnight travel.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

Medical, vision and dental insurance

Life and AD&D insurance

Paid holidays

PTO accrual

and much more!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com .

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.

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