Facilities Engineer

DirectSourceRx is building a state-of-the-art compounding and packaging facility that will serve patients in all 50 states. We need an experienced Maintenance & Reliability Engineer (often called Facilities Engineer, Equipment Engineer, Automation Engineer, or Manufacturing Maintenance Engineer) to own every piece of production equipment-from installation and validation to 24 7 uptime once we go live. You will be the site authority on automated filling, packaging, and compounding systems, ensuring they operate safely, efficiently, and in full compliance with FDA cGMP and USP standards.

Machine Installation

• Install and commission new pharmaceutical packing, compounding machines, and fully automated production lines.

• Coordinate with vendors and internal teams to ensure proper setup and functionality.

• Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) when applicable.

Troubleshooting & Root Cause Analysis

• Investigate equipment malfunctions and identify root causes.

• Implement corrective actions to resolve issues and prevent recurrence.

• Document all troubleshooting activities, solutions, and outcomes.

Preventive & Corrective Maintenance

• Develop and execute preventive maintenance schedules to minimize downtime.

• Perform corrective maintenance and repairs as needed, ensuring swift return to normal operations.

• Keep accurate records of maintenance activities and spare parts inventory.

Training & Instruction Preparation

• Develop comprehensive operator training programs and instruction manuals, SOP, and maintenance guides.

• Conduct in-person training sessions, ensuring operators are knowledgeable and compliant.

Regulatory Compliance

• Ensure all equipment and processes meet industry and governmental regulations (FDA, GMP, etc.).

• Collaborate with Quality Assurance and compliance teams to maintain strict adherence to standards.

Team Collaboration

• Work closely with the Engineering team to prioritize and execute assigned tasks.

• Collaborate with cross-functional departments (Production, Quality, Safety) for seamless operations.

• Provide technical support and guidance on equipment optimization.

• Share best practices and lead small improvement projects focused on efficiency and reliability.

Educational Background

• Bachelor's Degree (or higher) in Mechanical, Electronics, Electrical Engineering, or a related field.

Technical Expertise

• Experience with pharmaceutical packing machines, tablet compounding machines, machine automation, or similar equipment.

• Proficiency in basic software programming of logic control (eg, PLC).

• Hands-on experience in machine repair and troubleshooting.

Compliance Knowledge

• Familiarity with pharmaceutical regulations (FDA, GMP) is highly desirable.

Documentation & SOPs

• Proven ability to draft Standard Operating Procedures (SOPs) and work instructions.

• Excellent documentation and record-keeping skills.

Soft Skills

• Strong problem-solving and analytical thinking.

• Ability to work independently and within a team.

• Effective communication skills to liaise with engineers, operators, vendors, and management.

• Collaborate with engineers and vendors across different time zones, ensuring clear handovers, timely communication, and effective follow-through.

• Detail-oriented and capable of managing multiple tasks simultaneously.

Common search terms:

Maintenance Engineer Facilities Engineer Reliability Engineer Automation Engineer Equipment Engineer Pharmaceutical Manufacturing Compounding Packaging GMP PLC Sunrise FL