Maintenance Engineer

Maintenance Engineer

The Maintenance Engineer plays a critical role in ensuring the smooth operation and maintenance of all equipment, machinery, and facilities within the pharmaceutical manufacturing plant. This role requires a strong understanding of mechanical, electrical, and automation systems and a deep knowledge of pharmaceutical manufacturing processes and regulatory requirements. The Maintenance Engineer collaborates with cross-functional teams to maintain equipment reliability, optimize performance, and uphold safety and quality standards.

Reporting Relationships

• This position has direct reports.

Essential Functions

• Equipment Maintenance and Repair:
• Conduct routine inspections, preventive maintenance, and repairs on pharmaceutical manufacturing equipment, including but not limited to mixing machines, compression machines, encapsulation machines, coating machines, and packaging machines.
• Troubleshoot and diagnose equipment issues, perform root cause analysis, and implement effective solutions to minimize downtime. Respond promptly to equipment breakdowns and emergencies, working with urgency to restore operations while adhering to safety protocols.
• Conduct routine, periodic, or special inspections to determine repair and maintenance work necessary to prevent breakdowns of facilities' machinery and utility equipment.
• Collect quotations from vendors and create purchase requisitions for spare and repair parts. Maintain inventory of parts required for preventative maintenance.
• Coordinate with suppliers and vendors for spare parts procurement and ensure timely availability of critical components.
• Documentation and Compliance:
• Maintain accurate records of maintenance activities, including work orders, equipment history, and maintenance schedules.
• Write SOP, protocols, and maintenance reports for manufacturing and utility equipment.
• Authoring equipment specifications, user and functional requirements specifications, and necessary FAT.
• Ensure compliance with regulatory guidelines and company SOPs (Standard Operating Procedures) for maintenance and engineering practices.
• Continuous Improvement:
• Identify opportunities for process improvement, reliability enhancement, and cost reduction in collaboration with the engineering and production teams.
• Implement and participate in continuous improvement initiatives, including lean manufacturing and Six Sigma projects.
• Team
  
  Collaboration:
• Collaborate with cross-functional teams, including production, and quality control, to align maintenance activities with production goals and quality standards.
• Provide technical support and training to operators and technicians on proper equipment operation and maintenance.
• Safety and Compliance:
• Adhere to and promote a strong safety culture by following all safety procedures and protocols.
• Ensure that maintenance activities are conducted in compliance with environmental, health, and safety regulations.
• Assist in commissioning or qualification activities of site equipment, building, and utility systems.
• Set up and operate all tools and equipment necessary to perform assigned work.
• Assign work and resolve routine problems within the Maintenance Department.
• Review structural blueprints for new projects. Provide suggestions for change.
• All other job-related duties.

Specialized Skills and Knowledge:

• Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements (cGMP, FDA guidelines).
• Knowledge of Utility systems and HVAC systems.
• Proficiency in troubleshooting and repairing mechanical, electrical, and automation systems.
• Basic mathematical skills

• Excellent verbal and written communication skills in English
• Must complete departmental SOP, GMP, and any required Qualifications.
• Ability to work in a team environment.

• Follow all Good Manufacturing Practices (GMP) and guidelines. Must report unsafe conditions, near misses, and/or injuries in a timely manner.

Experience and

Education:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field. Master's degree is a plus.
• Minimum 3 years of experience repairing and maintaining pharmaceutical manufacturing and packaging equipment (oral solid dosage experience preferred).

Key

Competencies:

Physical Demands/Factors:

While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 55 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.

The physical demands described here are…