Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting new opportunity for a high performing Engineering professional looking to join and contribute to a high growth Biotech/Medtech company with multiple Cell Therapy products on the market as well as a strong balance sheet. Reporting directly to the Director, Operations at Vericel, this is a great opportunity to join an exciting and fast growing $2 Billion+ market cap life sciences company with a talented team of professionals who are committed to improving the lives of the patients we serve.
The Engineering department is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems.
- Select, develop, and motivate qualified staff to effectively carry out department functions and provide for the continuity of managerial and specialized skills.
- Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.
- Coach and mentor staff in all aspect of their job performance and career development including training, feedback, rewards and disciplinary action.
- Develop work plans, assign tasks, and supervise team(s).
- 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.
- Address and/or escalate site compliance issues
- Interact with project teams and cross-functional groups.
- Manage corrective, preventative and operation/monitoring programs in a manner ensuring facility personnel safety, continual cGMP compliance, capital investment protection and customer satisfaction.
- Actively oversee the daily operations and maintenance activities to assure compliance with all company and regulatory agency policies and procedures.
- Partner with other functional areas to effectively schedule maintenance activities, coordinate resources and assign work to direct reports.
- Work in a collaborative team environment and interact with other support groups such as Validation, Quality Assurance, Metrology and Scientific groups.
- Ensure schedule adherence and proper prioritization of workload.
- Put in place robust operations and maintenance strategy, spare parts inventory and assess areas for continuous improvement.
- Mentor and develop members of the Engineering group
- Manage all Engineering projects, ensuring timelines are met
- Represent the Engineering group during audits
QUALIFICATIONS, EDUCATION AND EXPERIENCE
An ongoing commitment to conducting business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery 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.
- Bachelor’s degree in Mechanical Engineering, or similar field.
- A minimum of 7 years of progressively responsible experience in a biotechnology manufacturing environment.
- Knowledge of cGMP, FDA and other pharmaceutical regulatory requirements.
- Strong documentation skills of maintenance records in a cGMP environment.
- Microsoft Office Suite computer systems skills with experience in a computerized maintenance management system.
- A proven track record of establishing and maintaining cooperative working relationships with internal customers, vendors, and direct reports.
- Proficient in CAD software, preferably AutoCAD.
- Experience in cGMP record review and regulatory audit participation.
- Knowledge of facility infrastructure
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Required to work while aseptically gowned in a clean room environment.
- Work may include working with tools, and some lifting.
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.