Job Summary 

The Manufacturing Maintenance Engineer is a senior level mechanical position, that primarily performs complex mechanical and electrical repairs to automated and semi-automated machinery. Specializing in detailed diagnostics of machine issues, utilizing schematics and detailed knowledge of mechanical principles. Ensures the efficient operation of equipment in manufacturing processes, focusing on continuous process and machine improvements.

The salary range for this position is currently $125,000-$150,000 annually. Individual compensation is based on the candidate’s qualifications for the position, including experience, skills, knowledge, education, certifications, internal equity, budget, and/or other business and organizational needs.

Key Accountabilities 

• • Subject matter expert in all mechanical and electrical systems, related functions and automated machines, including HVAC systems, and lyophilizing equipment. 
  • Oversee and carry out the diagnoses and repair of automated machinery. 
  • Utilize diagnostic tools and techniques to identify and resolve complex mechanical problems. 
  • Carry out work safely per OSHA regulated guidelines, and established safety procedures.  
  • Ensure compliance of FDA, ISO, OSHA, and GMP regulations and standards in regards to maintenance actions. 
  • Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.   
  • Maintain accurate records of maintenance and repairs, prepare reports, and communicate effectively with management and other team members. 
  • Work to identify improvements for cost and manual labor reduction, and to improve process/equipment yields; work with management to implement identified improvements.  
  • Support and drive change within the operation by establishing partnerships with peers, cross functional stakeholders, assigned staff and shop floor colleagues to align their actions with the process improvement efforts. 
  • Support daily production activities and goals; continuously work to ensure mechanical performance of equipment that supports timely release of product and avoids back orders. 
  • Support the installation, qualification, and validation of new equipment and processes. 
  • Support the engineering staff, R&D, and manufacturing operations personnel as required. 
  • Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures, and processes. 
  • Make recommendations for efficiency improvements, equipment purchases, and facility upgrades. 
  • Interface with regulatory agencies for site audits if called upon. 
  • Other duties as assigned. 

Networking/Key relationships 

• Manufacturing Production 
• Manufacturing Engineering 
• External Vendors  
• R&D 

Minimum Knowledge and Experience:

• Bachelor’s degree in engineering. 
• Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. 
• HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. 
• Experience with vision systems (e.g., Cognex) and PLC programming/software, including Allen-Bradley and Mitsubishi platforms. 
• Experience in managing Nonconformances (NCs) and Corrective and Preventive Actions (CAPAs). 

Skills & Capabilities: 

• Bachelor’s degree in technical background or equivalent work experience required. 
• Minimum of ten (10) years of mechanical and electrical experience in a regulated medical device manufacturing or pharmaceutical environment. 
• HVAC and lyophilizing system experience, including repairs and a proven ability to diagnose system issues. 
• Demonstrated high level of competency with automation assembly, including electrical and pneumatic installation/operation.
• Proficient ability to utilize mechanical diagnostic equipment including calipers, micrometers, gauges, humidity and temperature measuring devices. 
• Proficient ability to utilize electrical diagnostic equipment including multimeters, voltmeters, ohmmeter, wattmeter, and related instruments. 
• Expert in mechanical and electrical theory. 
• Self-motivated with the ability to work independently and as part of a team. 
• Must have a high understanding of electrical and mechanical schematics. 
• Familiarity with GDP, GMP, Food and Drug Administration (FDA), ISO 17025, ISO 9000, and Occupational Safety and Health Administration (OSHA). 
• Working knowledge of Microsoft Office Suite. 
• The ability to communicate effectively with various departments within the company to achieve key performance targets.  
• Work with vendors to source machine components, and on-site repairs.
• Report on management of any issues that affect production output or safety.