Responsibilities:

• Process Equipment Maintenance:
  Perform preventative maintenance and repairs on process equipment, including bioreactors, centrifuges, ultrafiltration skids, parts washers, autoclaves, isolators, and fillers in a GMP environment.

• Preventative Maintenance Planning:
  Provide recommendations for preventative maintenance plans to minimize downtime, ensuring efficient and reliable operation of critical process systems.

• SOP Development & Revisions:
  Contribute to the creation and revision of Standard Operating Procedures (SOPs) for process maintenance activities, ensuring alignment with GMP and safety standards.

• Troubleshooting and Diagnostics:
  Diagnose and troubleshoot equipment malfunctions promptly, addressing issues to minimize production downtime.

• Installation and Commissioning:
  Assist with the installation and commissioning of new process equipment, ensuring proper integration with existing systems.

• Documentation & Record Keeping:
  Maintain accurate maintenance records and documentation to ensure compliance with GMP and other regulatory requirements.

• Safety and Compliance:
  Follow SOPs to ensure compliance with GMP standards, Environmental Health & Safety (EHS) protocols, and safety best practices. Report any unsafe conditions or hazards immediately.

• Off-Hours Support:
  Support site operations and emergency work orders during off-hours, as required, to ensure continuous operation of critical systems.

• Spare Parts Assessment:
  Perform spare parts assessments as needed, ensuring the availability of necessary components to support maintenance activities.

• Transition to Commissioning & FAT:
  Transition to commissioning and validation responsibilities between August and December, with potential to support Factory Acceptance Testing (FAT) for two buildings under construction.

• You possess solid knowledge of mechanical, electrical, and control systems as well as GMP requirements.
• You are a proactive problem-solver with strong troubleshooting skills and the ability to handle complex equipment issues.
• You have excellent communication skills, both written and oral, and the ability to collaborate in a team environment.
• You understand the importance of preventative maintenance and have experience with Computerized Maintenance Management Systems (CMMS).
• You are committed to adhering to safety and compliance protocols, ensuring a high standard of quality and safety at all times.

• High School Diploma or GED required.
• 4+ years of maintenance experience in a pharmaceutical or similar manufacturing environment.
• Experience with Computerized Maintenance Management Systems (CMMS).
• Strong knowledge of mechanical, electrical, and control systems.
• In-depth understanding of GMP requirements.
• Excellent written and verbal communication skills.
• Ability to work effectively in a team environment.
• Familiarity with lean manufacturing principles and time management skills.
• Ability to train and mentor other team members.

• Associate degree in Mechanical, Electrical, or Chemical Engineering, or a related field.
• 5+ years of maintenance experience in a pharmaceutical or similar manufacturing environment.
• Certification as a Certified Maintenance & Reliability Professional (CMRP) or Certified Maintenance & Reliability Technician (CMRT).
• Experience with gowning in a Class C environment (preferred for potential extension).
• Experience with utilities in a GMP setting is a plus.