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The Lead Technician is responsible for Preventive Maintenance, Corrective Maintenance, and troubleshooting of refrigeration equipment at the Collagen Manufacturing Center (CMC). Refrigeration equipment includes compressors, lyophilizers, condensers, WFI still, etc.  

The Lead Technician works in all areas in manufacturing so gowning to work in Clean Spaces may be required. The Lead Technician ensures that all maintenance activities protect the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protect patient safety.

To succeed in this role, the Lead Technician is responsible for:

Safety - Ensures that all team members receive training from Integra LifeSciences’ Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, and awareness. Initiates accident, near miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained.  Reviews MSDS in advance of work, and where required.  Follows EPA Section 608 requirements for handling refrigerants.Quality - Responsible for team’s compliance and meeting the quality standards as defined by Integra’s SOPs, GMPs, Global Quality Standards, local and procedures, where applicable. Manage People Effectively – Interfaces with other Maintenance staff, managers and operators in manufacturing and administrative settings.Lead Refrigeration Technician Excellence -Imparts a culture of 6S and continuous improvement in all maintenance activities.Receives work tickets from the Maintenance Supervisor or Maintenance Planner.  The work tickets may be for Preventive or Corrective Maintenance tasks.Ensure that the recipient manufacturing departments are informed of the maintenance activities.In cases where refrigerant contact is possible: Uses PPE for handling refrigerants including gloves, goggles, respirators, and protective clothing to avoid contact. Gather necessary tools and spare parts.Follows EPA Section 608 requirements for handling refrigerants and for protecting other workers and the environment.Install, inspect, test, troubleshoot, adjust, repair to perform preventative or corrective maintenance work on refrigeration equipment.Document work on the work ticket, including any follow up activities. and required. Informs the Maintenance Supervisor if any follow-up tasks required and any spare parts needed.Document PM or CM on batch records or room logs to cross reference with work tickets, where required.Serve as a project resource to engineering / validation group to assist in the follow up and timely implementation of projects and validation activities.Informs the Maintenance Supervisor of opportunities for continuous improvement.Must be available to work during July and December shutdowns.Must use PPE inclusive of gloves, goggles, face shields, head coverings, full head and body suits, and respirators where appropriate and whenever working in Clean Spaces.Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs, as required.Requires specialized refrigeration technical expertise within an analytical/scientific method or operational process to perform a broad range of complex work assignmentsCompletes assignments and facilitates the work activities of others; may coordinate work beyond own areaMay act as a team lead, providing subject matter guidance to team members but is not a supervisorWorks autonomously within established procedures and practices; proposing improvements to processes and methods as neededUnderstands how own and related teams efforts impact broader organizational objectives tied to customers' needsImpacts the effectiveness of own team and closely related teamsMay act as a team lead, providing subject matter guidance to more junior team members – but is not a supervisorGathers and analyses data to identify and solve complex problems that arise with little or no precedentExchanges advanced technical information and ideas effectively; uses tact and diplomacy when interacting with own and other teams

DESIRED MINIMUM QUALIFICATIONS

High School Diploma, Vocational, Certification or equivalent with 8+ years of experience.EPA Section 608 or Section 609 Certification to handle refrigerants and refrigeration equipment.5+ years refrigeration maintenance experience in FDA-regulated environment is preferable.Knowledgeable in 6S execution in all aspects of maintenance services is preferable.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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