Manufacturing Engineer - Katalyst Healthcares & Life Sciences
Cary, IL 60013
About the Job
Responsibilities:
Requirements:
- We are currently seeking a Manufacturing Engineer contractor to join our Manufacturing Engineering team in Cary, IL.
- The Manufacturing Engineer contractor will become part of a highly engaged, driven and successful team in support company's unique portfolio of medical device, drug and cosmetic products produced at our world-class manufacturing facility.
- Collaborative partners. People who build and leverage cross-functional relationships bring together ideas, data and insights to drive continuous improvement.
- Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
- Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
- Dedicated achievers.
- Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
- Provide engineering support for custom automation equipment for the high-volume manufacture of medical devices.
- Provide technical, engineering, validation and documentation support.
- This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.
- This position requires professional mastery of a specialized field of expertise that typically requires a college degree or equivalent.
- The job requires professional knowledge gained through substantial applicable work experience, to supplement formal knowledge, in order to apply principles and concepts of own subject/technical discipline in resolving issues as they arrive.
- The job requires attention to detail in making evaluative judgements based on the analysis of factual information.
- This job typically requires a 4-year engineering degree and 2 years of industry experience.
- Support engineering and project management in FAT, installation, and commissioning of new equipment.
- Develop and maintain process FMEAs and control plans for new and existing equipment.
- Complete process validations including VP, URS, IQ, OQ, PQ and associated documentation.
- Develop appropriate supporting documentation, SOPs and work instructions compliant with Good Manufacturing Practices (GMP).
- Collaborate with product and manufacturing engineering, equipment vendors, maintenance technicians and operations leadership to troubleshoot process and equipment issues.
- Support line performance monitoring and lead practical problem solving (PPS) projects to remediate systemic issues.
Requirements:
- B.S. in Engineering or related field required.
- Two years' experience in manufacturing engineering, mechanical engineering, or related field.
- Demonstrated interest and experience supporting manufacturing operations, troubleshooting automation equipment, and implementing process improvements.
- Medical Device industry experience (i.e., internship).
- Demonstrated experience writing and executing validations (IQ, OQ, PV, etc.).
- High speed custom automation experience.
Source : Katalyst Healthcares & Life Sciences
