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SUMMARY DESCRIPTION

The Senior Engineer, Automation, is responsible for the firmware, logic, code generation, documentation, backups, troubleshooting, and optimization of automated systems in use at the Product Development and GMP manufacturing areas of the Collagen Manufacturing Center (CMC). Inclusive in this role are WFI, CCA, PS, and other utilities as necessary. The incumbent applies Best Engineering Practices and sustainability initiatives to optimize Asset Life Cycle Management. The incumbent monitors performance and uptime of automated systems in support of supply chain integrity by keeping them in a state of continuous compliance and inspectional readiness. For project work, the incumbent translates the needs of stakeholders into automation code planning, execution, validation, and handover. The Senior Engineer, Automation, ensures that the execution of duties protects the identity, quality, durability, reliability, safety, and effectiveness of medical devices and, thereby, protects patient safety.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Safety - Ensures that all team members receive training from Integra LifeSciences’ Safety department, and are knowledgeable and compliant regarding safety procedures, policies, permits, practices, PPE, and awareness. Initiates and leads accident, near miss reviews and incident notifications. Ensures proper housekeeping procedures are maintained.

• Quality - Responsible for the 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 - Whereas the Senior Engineer, Automation, has no direct reports, the incumbent plays a key role in multidisciplinary teams in the duties exercised.

• Senior Engineer, Automation, Performance Excellence -

• Takes a holistic approach to Asset Life Cycle Management of automated systems inclusive of all parts and demands. The goal is to ensure that the automated systems remain within their validated states and in a constant state of continuous inspectional readiness.

• Constantly monitors the performance of automated systems ensuring that performance and use sufficiently support of the needs of Product Development and GMP manufacturing.

• Plays a key role in Technology Transfer ensuring that manufacturing specifications are well within critical utilities’ validated states.

• Keeps backups of current code and archives past code.

• Maintains necessary equipment to interface with controllers to inspect or to download code, regardless of the controller age.

• Plays a leadership role in trouble shooting, repairs, and restorations.

• Translate the needs of multidisciplinary stakeholders into equipment selection to replace aging equipment or increase capacity.

• Partners with relevant stakeholders to develop Validation master plans and protocols for new control code. Plays a leadership role in protocol execution, receipt of data, data analysis, discrepancy resolution, final reports, final approvals, and assembly of handover packages.

• Submits necessary Change Controls carrying them through closure and final approval.

• Coordinates work with the recipient departments.

• Assist in authoring SOPs for the use of automated systems.

• Actively participates in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs, as required.

DESIRED MINIMUM QUALIFICATIONS

• Bachelor's Degree in Engineering or relevant technical science, or military experience equivalent.

• 5+ years in the design, validation, and troubleshooting of automated systems for Product Development and GMP manufacturing in the FDA-regulated industries.

• Knowledgeable in various off-the-shelf software applications (MS Office, MS Project) and specialized applications for reading and generating automation codes.

• Strong problem-solving and analytical skills

• Ability to communicate effectively at all levels (both oral and written) both to in-house and external officials, where required.

• Medical device automated systems experience is preferred.

• Demonstrated ability to provide high-level customer service.

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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