Job Description

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

Facilitates, participates and assists with all aspects of production maintenance functions to support safety, regulatory compliance, asset management, continuous improvement and audit readiness throughout the North and West Warsaw campuses. The candidate must be technically competent in maintenance, reliability, quality, regulatory compliance, validation disciplines and processes as well as business performance metrics.

Principal Duties and Responsibilities

Prepares and maintains affectivity of maintenance procedures in regards to Quality System Regulation (QSR) equipment. Completes necessary reviews and updates of related procedures as required.
Participates in department activities to ensure compliance to 21 CFR 820.70(g) Equipment.
Develops work instructions and/or procedures for master data records to ensure data integrity of equipment and associated preventive maintenance records.
Provides technical support for new equipment design specifications and design enhancements to existing equipment.
Analyzes data and prepares reports for monthly, quarterly, and annual business needs based on organizational, business and team performance metrics.
Provides technical support for production maintenance technicians on equipment repairs.
Reviews and/or prepares the performance affected and return to service documentation related to maintenance work activities performed on QSR equipment.
Supports reliability engineering functions through root-cause analysis and historical trending of equipment failures to improve the preventive maintenance program, equipment availability and provide stable production and maintenance schedules.
Facilitates preventive maintenance (PM) schedules and PM compliance records.
Initiates and manages change control for preventive maintenance records.
Conducts training activities on maintenance processes and computerized maintenance management system.
Leads maintenance continuous improvement projects.
Leads and supports the IE / CAPA process for items related to maintenance and reliability.

Expected Areas of Competence

Experience with the GMP aspects that accompany operating in a FDA/ISO regulated industry
Knowledge and experience working in a maintenance organization in a regulated industry
Knowledge and experience of corrective & preventive maintenance processes
Knowledge and experience of equipment records and associated regulatory compliance
Knowledge and experience of equipment reliability processes
Technically proficient in machine repair (i.e. troubleshooting, diagnostics, failure analysis)
Experience with maintenance processes in regards to QSR equipment and 21 CFR 820.70(g) Equipment
Computer skills with various software applications including experience with CMMS SAP Maintenance Module
Ability to communicate with all levels of company hierarchy and have decision making abilities
Strong organizational and documentation skills
Fundamental understanding and application of root cause problem solving methods
Must be willing to travel to all Warsaw facilities on regular basis

Education/Experience Requirements

B.S. in the industrial technology capacity (i.e. mechanical/electrical engineering), or other engineering science plus a minimum of 3 years of manufacturing equipment support experience, or an equivalent combination of education and experience, preferably in an FDA regulated industry.
Knowledge and application of standard manufacturing core competencies:
Safety culture
Visual factory (e.g. 5S, 6S, workplace organization)
Lean manufacturing
Problem solving
Continuous improvement

Travel Requirements

Up to 5%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

EOE M/W/Vet/Disability