Senior Manager, Engineering and Maintenance

Responsibilities

• Lead a team of Process Engineers, Maintenance personnel, and Equipment Coordinators
• Manage equipment performance, preventive maintenance, and emergency repairs
• Oversee facility maintenance and building repairs
• Implement Total Productive Maintenance (TPM) programs to enhance production efficiency
• Support procurement of new process equipment, including user specification and commissioning
• Ensure compliance with cGMP, SOPs, and safety standards including LOTO and PPE
• Troubleshoot complex automated machinery, HMI, PLCs, and HVAC systems
• Drive continuous improvement using 6S and Root Cause Analysis (RCA) tools

Requirements

• BS degree in Engineering or a related field
• 7+ years of manufacturing experience
• 3+ years of leadership or supervisory experience
• Experience working in a cGMP environment
• Technical expertise in electrical, mechanical, and automated applications
• Knowledge of FDA guidelines and process validation
• Proficiency in Microsoft Office Suite and enterprise software like Maximo or Veeva
• Ability to travel up to 10%

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) that partners with pharmaceutical and biotech companies to bring sterile injectable products to market.