Senior Facility Engineer II, Automation & Controls

Integra LifeSciences Corporation; Plainsboro Township (NJ); On-site; USD 125,000 - 150,000; Full time

Job summary

A forward-thinking company is seeking a Senior Facility Engineer II to lead automation and controls in the healthcare sector. This role is pivotal in optimizing automated systems within the Product Development and GMP manufacturing areas, ensuring compliance and performance excellence. You will engage in critical tasks such as troubleshooting, code generation, and maintaining system integrity, all while collaborating with multidisciplinary teams. If you are passionate about engineering and making a tangible impact on patient outcomes, this is an exciting opportunity to advance your career in a dynamic environment focused on innovation and change.

Qualifications

• 5+ years in automated systems design, validation, and troubleshooting.
• Bachelor's Degree in Engineering or relevant technical science.

Responsibilities

• Ensure compliance with safety and quality standards in automated systems.
• Monitor performance and maintain automated systems for manufacturing.

Skills

Problem-Solving

Analytical Skills

Effective Communication

Customer Service

Education

Bachelor's Degree in Engineering

Military Experience Equivalent

Tools

MS Office

MS Project

Automation Software

Job description

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Facility Engineer II, Automation & Controls, 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.

• 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 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 troubleshooting, repairs, and restorations.

• Translates 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.

• Assists 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.