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The Project Engineer is responsible for initiation and implementation of facilities and equipment projects in the GMP manufacturing, laboratory, support, and non-GMP spaces of the Collagen Manufacturing Center (CMC). Projects range from construction, equipment specification, installation, qualification, rearrangements, specialty fabrications, and expansions, and may range upwards of $10M possibly spanning years. The Project Engineer is responsible for multidisciplinary project definition through project hand off, including validation/commissioning, with the goal of optimizing Asset Life Cycle Management and sustainability by using Good Engineering Practices in support of supply chain integrity. The Project Engineer ensures that the project planning and execution 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 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 Staff Engineer, Facilities, has no direct reports, the incumbent plays a key role in multidisciplinary teams in the duties exercised.
• Project Engineer, Performance Excellence –
• Takes a holistic approach to Asset Life Cycle Management of the GMP manufacturing facilities, utilities, and equipment. Projects within this role extend to mechanical spaces, offices, amenities, environmental controls, and safety. The goal is to ensure that the facilities remain within their validated states and in a constant state of continuous inspectional readiness.
• Constantly monitors the performance of all facilities ensuring that performance, upkeep, and use to support the needs of GMP manufacturing, and attendant groups.
• Plays a key role in Technology Transfer ensuring that manufacturing specifications are well within facilities’ validated states.
• Plays a leadership role in equipment trouble shooting, repairs, and restorations.
• Partners with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored GMP facilities/utilities/equipment. Plays a leadership role in protocol execution, receipt of data, data analysis, discrepancy resolution, final reports, final approvals, and assembly of handover packages.
• Responsible for attendant documentation, such as CAD drawings, city permits, safety permits, etc.
• Submits necessary Change Controls carrying them through closure and final approval.
• Coordinates work with the recipient departments.
• Plays a key role regarding facilities work during shut down maintenance cycles.
• Assist in authoring SOPs for the use and maintenance of the installed equipment.
• 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.
• 3 years in the engineering, construction, and care of facilities used GMP manufacturing in the FDA-regulated industries.
• Knowledgeable in various off-the-shelf software applications (MS Office, MS Project, CAD) and customized systems (CMMS)
• 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 critical Facilities 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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