Maintenance Manager

Overview

Simtra Bio Pharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement  hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Because we:

• Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.
• Make it RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

We are looking for a Maintenance Manager to lead a high-performance process maintenance team. This individual will be responsible for supporting the pharmaceutical manufacturing operations on a 24/7 basis. The role will drive timely and effective maintenance of all process equipment while improving the reliability of equipment. This individual will also manage the development and completion of preventative and predictive maintenance activities to ensure compliance with all GMP and safety regulations.

The Maintenance Manager reports to the Sr. Manager, Engineering & Maintenance and works 100% onsite at the Bloomington, Indiana facility.

• Manage and coach a team of Maintenance Technicians and Planners
• Responsible for process equipment maintenance, including but not limited to formulation equipment, filling lines, and autoclaves
• Monitors and drives key performance indicators (KPIs) related to equipment reliability and downtime reduction to ensure operational efficiency
• Ensures personnel completes all necessary training in a compliant manner
• Ensures all preventive and predictive maintenance is complete per schedule
• Ensures alignment of maintenance resources with business priorities
• Oversees spare parts inventory analysis and ensures appropriate inventory levels to support maintenance activities
• Coordinates accident investigations with EHS&S, as applicable, to identify root causes and implement preventive measures
• Assists engineering with development and implementation of preventive and predictive maintenance strategies
• Manages external contractors to ensure safe, efficient, and compliant execution of maintenance activities
• Maintains compliance with state, federal, and corporate safety and environmental regulations

• BS in Engineering, Maintenance Management, Industrial Technology, or a related field preferred; in lieu of education, extensive hands-on maintenance leadership experience
• 6+ years of progressive maintenance experience in a pharmaceutical, manufacturing, or industrial environment
• 3+ years experience in a supervisory or managerial role, with experience leading, coaching, and developing maintenance teams
• Strong understanding of processing equipment reliability, preventive/predictive maintenance, spare parts management, and contractor oversight
• Familiarity with CMMS (Computerized Maintenance Management Systems) and maintenance programs
• Experience in reading and…