The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.
- Lead Engineering specification, estimating, design, procurement, programming, installation management, startup, commissioning, and documentation of new systems and the ongoing support of existing systems.
- Provide cost estimates for new systems and equipment, and modifications or upgrades to existing systems.
- Lead design reviews, construction projects and installation support.
- Perform engineering startup, factory acceptance testing, commissioning, documentation, validation support and operator training.
- Provide day to day engineering support for process equipment such as Biosafety Cabinets, Cold Storage, Incubators, Ovens, Autoclaves, Heat Sealers, etc.
- Provide day to day engineering support for plant equipment such as RODI Water Systems, Vacuum Pumps, Air Compressors, HEPA Filtration, HVAC, etc.
- Create and edit SOPs and Quality System Records based on understanding of GMP Facility systems and Engineering Standards.
- Create engineering Reports and Protocols.
- Provide support for BMS controls, industrial process instrumentation and PLC control.
- Develop and maintain corporate engineering specifications, drawings and standards.
- Provide leadership, guidance, and direction to junior staff consistent with cGMP, good Engineering practices, and company corporate quality governance.
- Take a lead role in Engineering projects, by prioritizing work, developing work plans, and participating in cross-functional teams.
- Serve as an Engineering department SME where required, including audits, change controls, and deviation investigations.
- Provide expertise in process equipment design, specification development and installation of such equipment and systems.
- Author, review, and/or manage change controls and equipment deviations pertaining to the Engineering department in Trackwise.
- Act as Trackwise subject matter expert for Engineering department.
- Support the Facilities team in helping to troubleshoot utility and equipment problems, including outside normal working hours if necessary
- Other duties as assigned.
Qualifications, Education and Experience:
An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes:
- Respecting the laws and operating within the applicable regulations of the places in which we conduct business, as well as our own Company policies and procedures.
- Being honest and treating people with respect and courtesy.
- Constantly striving to make Vericel a great place to work, and a company respected for the quality of its people and products.
- Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs.
- Bachelor's degree in Mechanical, Chemical or Biomedical Engineering or equivalent engineering field or technical science and 3 or more years of relevant experience. Alternatively, a Master’s degree in an applicable field with 2+ years of relevant experience.
- Experience with commissioning, servicing and maintaining equipment in GxP environments.
- Experience with MS Office: Outlook, Word, Excel, PowerPoint.
- Experience in writing and editing Technical Reports and Protocols.
- Experience with Quality Systems.
- Proficient in CAD software, preferably AutoCAD.
- Exhibits strong communication stills and the ability to work in a cross-functional team environment.
- Experience with HVAC and related control systems.
- The ability to react to changing priorities based on manufacturing or business needs.
Working Conditions and Physical Demands
- May be required to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements.
- Required to work with hand tools.
- Work includes some lifting, up to 50 lbs.
All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.
Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.