Sr. Manager, Engineering and Maintenance

Simtra Bio Pharma Solutions is a world-class Contract Development Manufacturing Organization partnering with pharmaceutical and biotech companies to bring sterile injectable products to market. Facilities are in Bloomington, Indiana, US and Halle/Westfalen, Germany. Product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution, vaccines and related delivery systems. The company emphasizes quality, regulatory standards, and continuous improvement.

Primary focus is cGMP manufacturing with additional support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. The team is driven to help clients scale, innovate and bring medicines to patients worldwide.

Because we:

• Make it HAPPEN – We bring a growth mindset to every opportunity, develop new skillsets and exceed expectations and those of our customers.
• Make it TOGETHER – We work as one, respect every voice and tap into unique strengths across teams to solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling commitments to customers, patients and team members.
• Make it COUNT – We take pride in day-to-day work and the impact we make to improve patient health.

The Sr. Manager of Engineering & Maintenance (E&M) leads a team of Process Engineers, Maintenance personnel and Equipment Coordinators to support all aspects of secondary packaging for parenteral pharmaceutical products. This position is part of a cell-based building management structure, complemented by peer leaders from Operations, Quality, and Technical Services. The incumbent will lead a department with safety, quality, execution, collaboration and process improvement as foundational expectations to support cell operational metrics and plant goals.

The position reports to the Associate Director Engineering & Maintenance Operations.

• Maintain departmental headcount and all related administrative and planning functions, including interviewing, hiring, onboarding & training, personnel development, performance management, scheduling, directing day-to-day activities and project oversight.
• Oversee equipment performance, preventive/scheduled maintenance, emergency maintenance, vendor scheduling, and project management, including timely repair and sourcing of critical parts.
• Coordinate facilities maintenance activities and repairs for the building.
• Lead Total Productive Maintenance (TPM) program to identify overall equipment efficiencies and enhance production processes and quality.
• Support identification and procurement of new process equipment; generate user specification documents, manage installation, commissioning and qualification; oversee process engineers regarding project ownership and timelines with CAPEX colleagues.
• Collaborate with peer cell leaders to track and report department metrics within the cell.
• Identify and implement corrective actions to improve performance and compliance.
• Comply with SOPs, cGMP and rigorous quality standards; uphold these expectations with the team.
• Maintain a clean and safe work area using 6S principles.
• Ensure team compliance with safe work practices and electrical requirements, including LOTO, safe work permits, and PPE.
• Lead and/or support complex issues and projects as applicable.
• Apply technical expertise across technologies including syringe & vial aseptic filling equipment, autoclaves, lyophilizers, terminal sterilizers, isolator systems, HMI, PLCs, clean utilities, HVAC, SCADA and electrical control systems.
• Troubleshoot complex automated and manual/machine-based equipment.
• Fully accountable for the performance of self and team.

• BS degree in Engineering or a related field
• 7+ years of manufacturing experience
• Prior experience in a cGMP environment
• 3+ years of leadership/supervisory experience
• Demonstrated examples of successful project execution
• Technical management of process equipment in manufacturing with electrical, mechanical and automated applications
• Ability to analyze and solve complex problems
• Knowledge of GMPs, FDA guidelines, purchasing practices and process validation
• Experience guiding multi-disciplinary teams on medium complexity issues, providing technical direction
• Ability to translate business goals into action plans
• Reliability-centered maintenance principles and practice understanding
• Results-oriented mindset with independent thinking and adaptable to real-time situations
• Advanced proficiency in Microsoft Office
• Experience with enterprise software:
  Maximo, Veeva, Microsoft Dynamics, Blue Mountain
• Strong communication and technical writing skills
• Minimal travel (