What are the responsibilities and job description for the Plant Engineering Manager position at AQUABILITI?
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.
Key Responsibilities
Engineering and Maintenance Leadership
- Provide direct oversight and leadership to the Maintenance Supervisor and team.
- Develop and implement a comprehensive maintenance strategy, including preventative, and corrective maintenance programs.
- Ensure optimal staffing levels and training for the maintenance team.
- Foster a culture of continuous improvement, operational excellence, and accountability.
Capital Project Management
- Lead and manage capital projects, including equipment installation, facility modifications, and infrastructure upgrades.
- Develop project scopes, timelines, budgets, and resource plans.
- Oversee contractors, vendors, and internal teams to ensure projects are delivered on time and within budget.
Maintenance Management
- Establish and monitor key maintenance performance indicators (KPIs).
- Ensure the CMMS (Computerized Maintenance Management System) is accurately maintained to track work orders, preventative maintenance tasks, and spare parts inventory.
- Collaborate with the Maintenance Supervisor to optimize equipment reliability and reduce unplanned downtime.
- Lead root cause analysis for equipment failures and implement corrective actions.
Process Optimization and Continuous Improvement
- Implement Lean Six Sigma and other continuous improvement methodologies to enhance operational efficiency and reduce costs.
- Evaluate plant performance data to identify and prioritize opportunities for process improvement.
- Provide detailed cost estimates and justifications for projects and major maintenance activities.
- Lead cross-functional teams to execute improvement projects that increase OEE (Overall Equipment Effectiveness) and reduce waste.
Validation and Compliance
- Develop and execute validation protocols (IQ, OQ, PQ) for new and modified equipment, utilities, and processes.
- Collaborate with Quality Assurance to ensure all activities comply with FDA 21 CFR Part 820, ISO 13485, and cGMP standards.
- Maintain detailed validation and maintenance documentation to support regulatory audits.
Safety and Environmental Management
- Promote a strong safety culture across engineering and maintenance teams.
- Ensure compliance with OSHA regulations and AQUABILITI’s safety policies.
- Conduct regular safety inspections, implement corrective actions, and participate in incident investigations.
Qualifications
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or a related field.
- Minimum of 7-10 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.
Preferred Qualifications
- 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 water systems.