Maintenance Engineer

Avet Pharmaceutical•East Brunswick Township, NJ

About The Position

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.

Requirements

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.
Bachelor’s degree in Mechanical Engineering, Electrical Engineering, or a related field.
Minimum 3 years of experience repairing and maintaining pharmaceutical manufacturing and packaging equipment (oral solid dosage experience preferred).
Strong organizational and demonstrated leadership skills
Excellent verbal and written communication skills
Speed/Action/Simplicity/Initiative
Excellent problem-solving skills and ability to work under pressure.
Strong collaboration skills to work effectively across teams and with stakeholders.

Nice To Haves

Master's degree is a plus.

Responsibilities

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.