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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.

The Maintenance Services Manager is responsible for leading the Site Reliability Program and is focused on the development of effective maintenance strategies which improve the reliability and uptime of the process.

The Maintenance Services Manager will lead a team of Reliability Engineers and Process Engineers to drive improved Mean Time Between Failure (MTBF) metrics and process cycle-times. The team will be tasked with building the reliability infrastructure (master data, asset hierarchy etc.…), conducting detailed FMEAs, generating and analyzing failure history, developing technical training courses for the Maintenance Team, conducting process improvement studies for increased output, and supporting Capital Projects.

In addition, this role will support the Maintenance Manager by delivering technical training on all aspects of asset management and will support Process Teams by coordinating all activities and setting agendas and work packages.

Main Responsibilities:

• Develop and maintain a high-performing maintenance team through effective leadership, coaching, and mentorship.

• Develop the technical knowledge and capability of the Engineering Maintenance teams to maximize the reliability of plant and processes.

• Foster a collaborative and positive team culture, encouraging open communication and knowledge sharing.

• Conduct regular team meetings to review performance, address challenges, and celebrate achievements.

• Drive performance within the teams by setting SMART objectives and monitor progress by carrying out individual performance appraisals.

• Work closely with HR for talent acquisition, onboarding, and ongoing professional development of team members.

• Act as a liaison between maintenance and other departments to facilitate effective communication and collaboration.

Maintenance Strategy

• Formulate and implement a comprehensive maintenance strategy aligned with organizational goals and industry best practices.

• Develop and implement preventive and predictive maintenance programs, leveraging advanced technologies and data analysis to anticipate and address equipment issues.

• Collaborate with production and engineering teams to develop and maintain preventive maintenance strategies for all critical equipment.

• Continuously assess and optimize maintenance processes to improve efficiency, reduce downtime, and enhance overall equipment reliability.

• Participates and provides subject matter input for capital projects and problem-solving activities.

Compliance and Safety

• Ensure that all maintenance activities comply with relevant regulatory standards, including FDA, cGMP, and other applicable guidelines.

• Supports the development of a Health and Safety culture, through the implementation of safety protocols, and regular safety training sessions for maintenance staff.

• Provide guidance and support for new or complex maintenance activities.

• Conduct audits of work performed to ensure it meets current standards and requirements.

Maintenance Execution

• Collaborate with the Engineering team to identify opportunities for equipment upgrades, modifications, and optimizations to improve overall performance.

• Conduct root cause analysis for equipment failures and implement corrective actions to prevent reoccurrence.

• Revise maintenance policies and SOPs as needed.

• Collaborate with production, engineering, and quality assurance teams to ensure seamless integration of maintenance activities into overall operational schedules.

Documentation and Reporting

• 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.

• Generate regular reports on key performance indicators (KPIs), such as equipment uptime, maintenance costs, and workforce productivity.

• Provide timely and detailed reports to senior management highlighting maintenance achievements, challenges, and recommendations for improvement.

Budget Management

• Develop and manage the annual maintenance budget, providing regular updates to senior management on budget performance.

• Identify cost-saving opportunities without compromising the quality and reliability of maintenance activities.

• Work closely with the procurement team to negotiate contracts with external vendors and service providers.

Qualifications:

• BS in engineering or equivalent with 10+ year’s applicable experience, preferably including a minimum of 5 year’s supervisory experience.

• Experience with Pharma & cGMP is desirable.

• Evident business leadership skills and the ability to clearly communicate vision and strategy to various audiences.

• Ability to develop and nurture strong relationships.

• Ability to motivate, engage and develop strong teams.

• Excellent written and verbal communication skills

• Knowledge of manufacturing processes

• Working knowledge of electrical, mechanical, and basic PLC programming/troubleshooting

• Strong decision and problem-solving skills

• Strong analytical, planning, organizational and time management skills

• 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.

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.