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.

Supervise and operate for the day-to-day maintenance of utility systems, production equipment and facilities

Main Responsibilities:

Lead and supervise a team of maintenance technicians, providing guidance, coaching, and mentorship.

• Oversee the execution of preventive and predictive maintenance programs for production equipment, facilities, and utilities.

• Collaborate with the Reliability Engineers to implement condition monitoring techniques and predictive maintenance strategies.

• Ensure the timely completion of scheduled maintenance tasks, minimizing unplanned downtime.

• Champion a strong safety culture within the maintenance team, ensuring compliance with all safety regulations and protocols.

• Conduct regular safety training sessions, hazard assessments, and safety audits.

• Collaborate with regulatory affairs to ensure maintenance activities adhere to FDA standards and Good Manufacturing Practices (GMP).

• Participate in risk assessments and develop mitigation plans to address potential equipment failures.

• Lead and encourage the team to improve Health and Safety and working practices throughout.

• To ensure safe systems of work are deployed by compiling Risk Assessments / Method statements implementing actions and raising Permits to Work ensuring LOTO is executed as appropriate.

• Develop and manage work order systems to prioritize and schedule maintenance activities.

• Ensure accurate and detailed documentation of maintenance work, including logs, reports, and equipment history records. · Collaborate with the Engineering Planner to optimize work order efficiency and resource allocation.

• To ensure a timely reactive breakdown response through the team to production requirements, providing a rapid and knowledgeable approach to efficient and effective repairs to all aspects of production equipment and machinery, engaging all aspects of engineering expertise to reduce production down time

• Maintain accurate and up-to-date records of maintenance activities, including work orders, equipment manuals, and compliance documentation.

• Supporting, maintaining, and improving processes associated with the computerized maintenance management system for process reliability.

• Implement a comprehensive risk management strategy for capital projects, identifying potential risks and developing mitigation plans.

• Foster a proactive risk management culture within the team, encouraging ongoing risk identification and assessment.

• Conduct real-time adjustments to project plans based on evolving risk factors, ensuring project timelines and budgets are safeguarded.

• Establish a lessons-learned repository to capture and apply insights from past project risks and mitigations.

• Maintain open communication channels with cross-functional teams, including operations, engineering, and quality assurance.

• Collaborate with the Engineering Manager and Project Engineers to support capital projects and their integration with maintenance activities.

• Provide regular updates to leadership on maintenance performance metrics, challenges, and improvement initiatives.

• Shift handovers to be carried out with full transparency to ensure all parties are fully conversant with the daily activities currently happening along with previous events for information and pending planned activities to be carried over.

• Lead and actively participate in continuous improvement initiatives to enhance maintenance processes and overall equipment reliability.

• Implement best practices and lessons learned from root cause analyses and equipment failure investigations.

• Encourage innovation among the maintenance team, driving efficiency improvements and cost savings.

Qualifications:

• High School Diploma or GED. College degree preferred.

• Technical/working knowledge of Mechanics and Utilities, including but not limited to, Boilers, Air Compressors, WFI Stills, Heat Exchangers, Pumps, Process Tanks, Agitators, Clean In Place (CIP) skids, Ultra-Filtration skids, Chromatography skids, Centrifuges, Filter Presses

• Working knowledge of computerized maintenance management systems.

• Pharmaceutical experience, work in GMP environment required

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.

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.