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Gross remuneration 25000.00 - 35000.00 € Yearly
Responsible for providing sterilization-engineering support to Medline Industries worldwide operations. This role will assist/direct the design, installation, commissioning and start-up of facility sterilization process, abatement equipment [EO, Radiation], where needed, and ancillary supporting systems. Moreover, this role will drive projects with existing sterilization modalities that enhance Quality/Reg. Compliance, reduce operating costs through cost reduction, improved process control or improved machine reliability.
- Sterilization engineering support for greenfield and brownfield ethylene oxide sterilization facilities. This includes developing standardized URS, HAZOP/pFMEA/PHA, Risk Assessments, FAT, SAT and IQ documentation. With internal/external resources develop a sustainable model for sterilization facilities, minimizing bespoke costs.
- Lead stress testing of suppliers control system software and integration of controls w/process for a given sterilization modality.
- Engineering support for Sterility Assurance activities related to alternative sterilization methodologies, such as, but not limited: Ebeam, X-Ray, Aseptic Processing, Moist and ry Heat. This will include performing in-house engineering feasibility studies, design and qualification specifications for said methods on an industrial scale. Drive approved alternative methods to completion.
- Review existing in-house sterilization equipment, to include Control System Software, and ancillary systems for gaps and improvement opportunities. Prioritize improvements in accordance with business risk. Provide technically competent solutions, to include time-line for completion and budgetary considerations. Depending on site/team skill set, either marshal/oversee resources or direct internal/external resources for improvements. Provide training as necessary to improve internal skill set.
- Provide engineering solutions at existing sites to automate/integrate pallet conveyance throughout in-house EO facilities, collaborating w/Engineering, Quality and Operations.
- Standardize means/methods at internal sterilization sites, brown or greenfield. Where applicable, control system hardware and software, instrumentation, calibration and maintenance activities are primary drivers. Insure each sites%26rsquo; critical sterilization component/equipment/software has a backup to minimize risk and insure business continuity.
- Support Sterility Assurance team with IQ/OQ/PQ, Risk Assessments, CAPA%26rsquo;s, Audits, etc.
- Benchmark internal/external sterilization modalities, insuring best practices for Medline owned sterilization equipment/facilities.
- Working understanding of US and International regulations associated with various modes of sterilization, specifically EO.
- This is a high-level individual contributor role. May be involved in hiring staff, recommending pay increases, performing performance reviews, training and development of staff, estimating personnel needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies.
Please be aware that Medline requires all employees starting in this position to be fully vaccinated against COVID-19. This position will require the successful candidate to provide proof that they are fully vaccinated by their start date. Medline is an equal opportunity employer, and will provide reasonable accommodations to those individuals who are unable to be vaccinated for COVID-19 consistent with federal, state, and local law.
- Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, or equivalent mechanical/electrical degree. A Life Science degree with a minimum 10 years demonstrated professional engineering roles/expertise is acceptable.
- A minimum 10 year sterilization equipment experience required. SME in ethylene oxide sterilization equipment (primary)/processes (desirable) from an engineering perspective. Secondary expertise in other methodology is desirable, such as, but not limited to: E-beam, X-Ray, Gamma, Dry Heat, Moist Heat, Aseptic or novel sterilization methods.
- Preferred 10+ years hands-on-of experience in a regulated industry, with sterilization engineering, EO required, Dry or Moist Heat desirable.
- A Controls/Automation background is required; 8+ years%26rsquo; experience with Sterilization Software Programming & Integration.
- Proficiency in AutoCAD required, as well as Microsoft Suite [Word, PowerPoint, Excel, and Project]. Statistical analysis desirable using Minitab or equivalent.
- Ability to work effectively in cross-functional teams. Ability to work independently and manage multiple tasks and priorities.
- Position requires travel up to 30% of the time for business purposes (domestic and international).
- Sterilizer equipment, and Controls Hardware and Software. Relevant standards associated with EO modality.
- Benchmarking and project management skills to develop scope, capital cost, and timelines in support of capital projects.
Required skills :
- Stress testing
- Software Integration
- Hardware design
- Physical plant
- Hardware (computer)
- Software (computer)
- Power engineering
- Manufacturing or operations
- Manage priorities
- Biomedical Engineering (BME)
- Mechanical engineering
- Law (legal science)
- Process FMEA (PFMEA)
- Control System
- Project Management
- Autodesk AutoCAD
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint