- 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.
- Understanding, observing, and adhering to the goals and policies outlined in Vericel's Code of Business Conduct and Ethics
- 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. · Serving as role models for our fellow employees and business partners 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
- 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.
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Engineer III - Cambridge, United States - Vericel Corporation
Description
Job Description
Job DescriptionVericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Engineering professional looking to join and contribute to a commercial stage company with an established portfolio of unique advanced cell therapies and specialty biologics. Reporting directly to Engineering Management at Vericel, this is a great opportunity to join a high growth company with a strong balance sheet supported by a talented team of professionals who are committed to improving the lives of the patients we serve.
POSITION SUMMARY
The Engineer III is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems. Additional responsibilities include supporting & leading capital projects, lean initiatives, cross functional teams and vendor management.
DUTIES AND RESPONSIBILITIES
Essential Functions:
Leadership Responsibilities:
QUALIFICATIONS, EDUCATION AND EXPERIENCE
Preferred Qualifications:
WORKING CONDITIONS AND PHYSICAL DEMANDS
EEO Statement
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.
