Job Overview
We're seeking a seasoned Maintenance & Reliability Supervisor to lead our equipment and facilities maintenance operations within a highly regulated manufacturing environment. This role is pivotal in ensuring equipment reliability, regulatory compliance, and team performance to support continuous production and operational excellence.
You'll oversee preventive and corrective maintenance for automated systems and packaging lines, manage calibration and validation programs, and drive improvements in Overall Equipment Effectiveness (OEE). As a people leader, you'll mentor a skilled team of technicians, foster a culture of continuous improvement, and collaborate cross-functionally to meet business goals.
This position requires strong technical expertise, leadership capabilities, and a deep understanding of regulatory standards such as FDA 21 CFR Part 820 and ISO You'll also manage budgets, vendor relationships, and safety initiatives, while implementing modern maintenance technologies and systems.
Job Requirements
* Equipment Management & Maintenance
* Supervise preventive and corrective maintenance programs for automated manufacturing equipment, packaging lines, and facility systems.
* Develop and implement maintenance schedules, procedures, and work instructions in compliance with medical device regulations
* Oversee calibration programs for critical measurement and control equipment
* Ensure equipment reliability and minimize unplanned downtime to meet production targets
* Responsible for machine availability and uptime in relation to Overall Equipment Effectiveness OEE
Team Leadership & Development
* Lead and mentor a team of maintenance technicians and specialists
* Conduct performance evaluations, training needs assessments, and skills development programs
* Schedule maintenance staff to provide 24/7 coverage as needed
* Foster a culture of continuous improvement and technical excellence
* Coordinate with HR for recruitment, onboarding, and retention of maintenance personnel
Regulatory Compliance & Documentation
* Ensure all maintenance activities comply with FDA regulations (21 CFR Part 820), ISO 13485, and other applicable standards
* Maintain detailed maintenance records, equipment histories, and compliance documentation
* Support regulatory inspections and audits related to equipment and facilities
* Implement and maintain validation protocols for equipment modifications and upgrades
Planning & Resource Management
* Develop annual maintenance budgets and manage spare parts inventory
* Plan and coordinate major equipment installations, relocations, and upgrades
* Evaluate and recommend new maintenance technologies, tools, and methodologies
* Manage relationships with equipment vendors, service providers, and contractors
* Implement computerized maintenance management systems (CMMS) and KPI tracking
Safety & Risk Management
* Ensure all maintenance activities follow safety protocols and requirements
* Conduct risk assessments for maintenance procedures and equipment modifications
* Investigate equipment failures and implement corrective and preventive actions (CAPA)
* Support environmental health and safety initiatives
Qualifications
What your background should look like
* Bachelor's degree in Engineering, Engineering Technology, or related technical field
* Minimum 5-7 years of maintenance experience in regulated manufacturing environments
* 3+ years of supervisory or leadership experience
Key Requirements
* Experience with medical device manufacturing or similar highly regulated industry (pharmaceutical, aerospace)
* Advanced degree in Engineering or Business Administration
* Professional certifications (Six Sigma, Project Management, Maintenance & Reliability)
* Experience with Lean Manufacturing and continuous improvement methodologies
* Knowledge of advanced manufacturing technologies (robotics, vision systems, etc.)
* Spoken and written English
* Ability to work flexible hours including evenings, weekends, and emergency calls
Technical Skills
* Strong knowledge of automated manufacturing systems, PLCs, and control systems
* Experience with preventive maintenance programs and reliability engineering principles
* Familiarity with FDA regulations, ISO standards, and validation requirements
* Proficiency with CMMS software and maintenance management tools
* Understanding of electrical, mechanical, pneumatic, and hydraulic systems
Leadership & Communication
* Proven ability to lead and develop technical teams
* Strong problem-solving and decision-making skills
* Excellent written and verbal communication abilities
* Experience with budget management and resource plannin
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Competencies
Values: Integrity, Accountability, Inclusion, Innovation, Teamwork