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Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

General duties will include testing and overseeing the care and maintenance of all production equipment and GMP utilities. The reliability engineer will support all major capital projects that on-board equipment. In addition, the reliability engineer will be responsible for ensuring all applicable equipment is placed in a compliant preventative maintenance system.

Main Responsibilities:

• Oversee the reliability programs for all production equipment and production control systems in the plant.

• Drive the implementation of reliability engineering practices and programs in the plant.

• Design and implement maintenance procedures and support maintenance management systems (i.e., CMMS) to assure compliance with fundamental maintenance standards and practices.

• Support metrology program to insure reliability of critical instrumentation.

• The position will be responsible for owning preventative maintenance SOPs and updating as applicable.

• Generate concepts/ideas that revolve around equipment/fixture type solutions.

• Design equipment/fixtures with deliverables that are aligned with the requirements of the manufacturing process stakeholders.

• Collaborate with the development team on new product introductions on the design & sourcing of custom equipment. The key skill will be the specifying of equipment.

• Obtain an in-depth knowledge of our existing manufacturing processes to enable cost reduction opportunities to be identified and assessed for appropriateness. Develop, analyze, and review a variety of operational reports to examine equipment usage, preventative maintenance, efficiency, quality, and other areas implements operational changes as required. This includes developing operating policies and procedures to ensure the efficient use of resources, maintain a safe environment, and produce quality products.

• Generate & manage a detailed Project Plan that ensures equipment/fixture solutions are implemented into the manufacturing area in an effective & timely fashion. Successful implementation will involve building up a strong working relationship with all the manufacturing process stakeholders. Support capital projects (includes aiding in the, installation, commissioning, validation, and other related on-boarding activities). Activities to include authoring User Requirement Specifications, Functional Requirement Specifications, Design, and equipment specifications.

• Ensuring all applicable equipment is placed in a compliant preventative maintenance system. Oversee the reliability programs for all production equipment and production control systems in the plant. Drive the implementation of reliability engineering practices and programs in the plant. Design and implement maintenance procedures and support maintenance management systems (i.e., CMMS) to assure compliance with fundamental maintenance standards and practices. The position will be responsible for owning preventative maintenance SOPs and updating as applicable.

• Support continuous improvement efforts, particularly related to minimizing equipment downtime.

• Maintains a safe work environment and ensures compliance with safety policies and rules.

• Shares responsibility of self-development with immediate supervisor.

• All other duties as assigned

Qualifications:

• BS degree in a sub-field of engineering, such as electrical or mechanical from an accredited college or university.

• Minimum of 5 years’ experience as an equipment engineer in a pharmaceutical environment is preferred

• Proven ability to drive results to achieve financial goals

• Collaborative and inclusive leadership style

• Willingness to work weekends and holidays when operating conditions require

• Ability to physically perform requirements of working in a 24/7 operating facility, to include ability to work in extreme temperatures and be ambulatory in an industrial environment with catwalks and uneven surfaces.

Kedrion Biopharma offers a number of benefits to 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!

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Salary Range: $90k - $135k

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

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.