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Manufacturing Engineer I
1 month ago
Join Integra LifeSciences, a leading medical device company, as a Manufacturing Engineer I and play a key role in shaping the future of healthcare.
Job Summary:The Manufacturing Engineer I is responsible for the initiation and implementation of facilities and equipment projects in the GMP manufacturing, laboratory, support, and non-GMP spaces of the Collagen Manufacturing Center (CMC). This role involves project planning, execution, and validation, with a focus on optimizing Asset Life Cycle Management and sustainability.
Key Responsibilities:- Initiate and lead accident, near miss reviews, and incident notifications.
- Ensure proper housekeeping procedures are maintained.
- Manage people effectively, playing a key role in multidisciplinary teams.
- Constantly monitor the performance of all facilities, ensuring they remain within their validated states and in a constant state of continuous inspectional readiness.
- Partner with relevant stakeholders to develop Validation Master Plans and validation protocols for new or restored GMP facilities/utilities/equipment.
- Play a leadership role in equipment trouble shooting, repairs, and restorations.
- Responsible for attendant documentation, such as CAD drawings, city permits, safety permits, etc.
- Submit necessary Change Controls carrying them through closure and final approval.
- Coordinate work with recipient departments.
- Play 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 participate in cross-functional teams addressing Deviations, Non-Conformances, and CAPAs as required.
- Bachelor's degree in Engineering or relevant technical science, or military experience equivalent.
- 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, 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.
