Manufacturing Engineer I
1 month ago
Integra LifeSciences is seeking a highly skilled Manufacturing Engineer I to join our team. This role 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).
Key Responsibilities- Initiate and lead facilities and equipment projects, including construction, equipment specification, installation, qualification, rearrangements, specialty fabrications, and expansions.
- Develop and implement project plans, ensuring timely and within-budget completion.
- Collaborate with multidisciplinary teams to define project scope, goals, and objectives.
- Ensure compliance with Integra's SOPs, GMPs, Global Quality Standards, and local regulations.
- Monitor and maintain facilities and equipment performance, ensuring continuous inspectional readiness.
- Participate in technology transfer, ensuring manufacturing specifications are well within facilities' validated states.
- Lead equipment troubleshooting, repairs, and restorations, and develop validation master plans and protocols.
- Coordinate work with recipient departments and submit necessary change controls.
- 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, with ability to communicate effectively at all levels.
- 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.
This site is governed solely by applicable U.S. laws and governmental regulations.
Integra LifeSciences is committed to providing qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA.
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