Ultimate Staffing ยท 3 weeks ago
Process/Maintenance Engineering Manager
Raleigh, NC
Full-time
Onsite
Senior Level, Lead/Staff
$115K/yr - $122K/yr
8+ years expUltimate Staffing is seeking a Process and Maintenance Engineering Manager responsible for leading engineering and maintenance functions to ensure optimal equipment reliability and operational efficiency. This role involves managing the Process Engineering team, overseeing maintenance programs, and ensuring compliance with regulatory standards.
EmploymentHuman ResourcesManufacturingStaffing Agency
Hiring Manager
Melanie Stiles
Responsibilities
Lead and develop the Process and Maintenance Engineering team, fostering technical expertise and continuous improvement culture
Design and sustain preventive and predictive maintenance programs, ensuring reliability and efficiency of manufacturing and utility systems
Drive process optimization projects to improve equipment performance, reduce costs, and enhance operational efficiency
Ensure compliance with GMP, FDA, and corporate standards in all engineering and maintenance activities
Oversee and coordinate CAPA, change control, deviations, and exception investigations related to engineering and maintenance operations
Develop, review, and approve SOPs, work instructions, and technical documentation for maintenance and engineering processes
Collaborate with Quality, Production, and Validation teams to ensure alignment on system ownership and improvement plans
Establish and monitor performance metrics and dashboards for maintenance effectiveness, reliability, and compliance
Provide leadership, coaching, and technical support to engineers, compliance specialists, and maintenance personnel
Support capital and expense planning through equipment condition assessments and reliability data analysis
Maintain engineering document control for equipment, utilities, and facilities
Ensure audit readiness and regulatory inspection support through robust documentation and compliance practices
Track and report compliance-related action items, including CAPA aging, change control cycle time, and PM completion rates
Lead training initiatives for engineering and maintenance teams to reinforce compliance and technical best practices
Qualification
Required
Bachelor's Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required
8-10 years of experience in maintenance, reliability, or process engineering management within a pharmaceutical or regulated manufacturing environment
Strong knowledge of preventive and predictive maintenance strategies, reliability engineering principles, and process optimization
Proven ability to lead CAPA, change control, and compliance documentation processes
Demonstrated success in leading technical teams and driving continuous improvement
Strong understanding of GMP, FDA, and ISO regulations
Excellent analytical, organizational, and communication skills
Proficient in Microsoft Office and Quality Management Systems (QMS)
Preferred
Master's Degree in Engineering (Mechanical, Electrical, Industrial, or related field)
Experience with CMMS systems (Maximo preferred)
Company
Ultimate Staffing
Ultimate Staffing specializes in clerical, administrative, customer service, and manufacturing and production positions.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Lisa Marez
Partnership Director
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