Job Description

Company Description

AQUABILITI is a leading manufacturer of compendial waters for the Life Sciences, CGT, Biotech, Medical Device, and Pharma industries. Our core products include USP Grade Water for Injection, Water for Irrigation, and Purified Water.

We also manufacture Pre-filled Saline Flush Syringes, including Sterile Field Ready (SFR) and Sterile Fluid Path/Contents (SFP) products for the healthcare sector. Our commitment is to provide top-quality solutions tailored to meet industry standards.

Role Description

This is a full-time on-site role located in Nashville, TN, for a Plant Engineering Manager. The Plant Engineering Manager at AQUABILITI is responsible for leading the engineering and maintenance functions to ensure the reliability, safety, and efficiency of plant operations. This includes oversight of all equipment, facilities, and utilities, with a strong focus on continuous improvement, compliance, and operational excellence. The Plant Engineering Manager will manage capital projects, lead engineering initiatives, and supervise the Maintenance Supervisor to ensure preventative and predictive maintenance programs are effectively executed. This role will collaborate cross-functionally with Quality and Operations teams to meet plant performance goals and ensure compliance with FDA, ISO, and GMP standards.

Qualifications

• Engineering Management and Team Leadership skills
• Experience in Project Management and Integration
• Strong ability to work on-site and lead teams effectively
• Excellent problem-solving and organizational skills
• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Engineering or related field
• Minimum of +5 years of experience in engineering and maintenance management within a regulated manufacturing environment, preferably medical devices.
• Demonstrated leadership in managing capital projects, maintenance teams, and continuous improvement initiatives.
• Excellent problem-solving, leadership, and cross-functional collaboration skills.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and cGMP regulations.
• Proficiency with CMMS, SCADA systems, and industrial automation.
• Experience in the manufacturing or healthcare industry is a plus

Preferred Qualifications (not a must)

• Project Management Professional (PMP) or Six Sigma Black Belt certification.
• Experience with syringe filling lines, labeling systems, packaging machines, and robotic systems.
• Experience with cleanroom environments and validation protocols.
• Working knowledge of facilities management, including HVAC, compressed air and the like.

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