The Engineering department is responsible for the preliminary through detailed design of manufacturing equipment, facility and utility systems, system start-up, troubleshooting, commissioning, validation, and ongoing support, maintenance and optimization.
- Assist in selection, training and development of junior engineering staff to effectively carry out department functions and provide for the continuity of specialized skills.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Take the lead role in Engineering projects, by prioritizing work, developing work plans, assigning tasks to other engineers, and supervising cross-functional teams.
- Ensure staff has appropriate knowledge of department processes and procedures.
- Provide input into the department budget.
- Establish and report applicable department or organizational metrics.
- Accountable for project completions and achievement of compliance goals.
- Represent the Engineering department in project team meetings.
- Serve as an Engineering department SME where required, including audits, change controls, and deviation investigations.
- Manage and/or Interact with project teams and cross-functional groups.
- Serve as the liaison between Engineering and other functional groups, including Facilities, Validation, Quality and Manufacturing.
- Lead a group of engineers focused on engineering operations.
- Develop work plans and provide guidance and direction to junior engineers.
- Lead engineering efforts from preliminary/detailed design, commissioning and startup of projects.
- Provide expertise in process equipment design, specification development and installation of such equipment and systems.
- Author, review, approve and manage change controls and equipment deviations pertaining to the Engineering department in Quality System.
- Act as Quality System 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
Scope and Impact:
- Work is subject to little or no review.
- Guide the successful completion of major programs through subordinates.
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 or equivalent in biomedical, chemical, or mechanical engineering or technical science and 3 or more years of relevant experience.
- Master’s degree and 1 or more years of relevant experience.
- Excellent communication and technical writing skills.
- Experience in working in a cGMP environment.
- Experience at supervising multi-disciplined technical staff and experience in supporting pharmaceutical manufacturing operations.
- Possess strong leadership and communication skills, work well in a team environment, and be able to react to changing business needs.
- Experience with Trackwise is a plus.
- Experience with installing and maintaining cleanroom HVAC systems preferred.
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.
- Work may include working with tools, and some lifting (up to 50 lbs.)
- Work may occasionally be scheduled after hours, including weekends.
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.