Associate Director, Engineering
Associate Director, Engineering
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 aspects 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 department in project team meetings.
- Interact with project teams and cross-functional groups.
- Address and/or escalate site compliance problems and issues.
- Lead and facilitate meetings/workshops.
- Develop and implement site-wide and departmental performance goals. Provide regular reports on progress towards completion
- Represent the company in interactions with external contractors and consultants.
- 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 junior Engineers
- Manage all Engineering projects, ensuring timelines are met
- Represent the Engineering and group during audits
- Design and implement upgrades to facilities and equipment in order to meet Vericel corporate objectives, and production targets
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.
- Bachelor’s degree in Mechanical Engineering, or similar field.
- A minimum of 5 years of progressively responsible Management experience in a bio-technology 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.
- Must possess comprehensive knowledge of building infrastructure and utility systems.
- Experience in managing and coordinating multiple service contractors during system shutdowns.
- Experience in issuing: hot work permits, confined space permits, ceiling entry permits, equipment release forms, action notifications.
- Experience in prioritizing scheduled work orders and emergency work requests in a 24/7 bio-technology manufacturing facility.
- Experience in cGMP record review and regulatory audit participation.
- Prior military or maritime academy experience.
- Construction management experience.
WORKING CONDITIONS AND PHYSICAL DEMANDS
- Off shift accessibility is required.
- Job requires physical work, including lifting
- Job requires gowning for access to cleanroom areas
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.