Vericel 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 Operations/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 Sr. Facilities Engineer is responsible for the supporting the startup, troubleshooting, commissioning, qualification, and engineering lifecycle initiation of manufacturing equipment, utilities and the facility.
DUTIES AND RESPONSIBILITIES
Essential Functions:
- Work with engineers, contractors and consultants to carry out large scale Capital Projects.
- Implement and Execute Good Engineering Practices GEP to support project Engineering Deliverables.
- Develop work plans and manage assigned tasks by working cross-functionally as needed.
- Approach work with the owner’s perspective for design build projects.
- Lead selected project teams and cross-functional groups in the areas of process equipment and building utilities maintenance development. Including SOP and PM generation.
- SME on project Risk Assessments, Engineering and Validation Lifecycle, and other compliance document reviews.
- Manage internal resources as project SME to complete deliverables and mitigate risks.
- Interface with Engineering group to align existing internal systems with project needs.
- 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.
- Support robust operations and maintenance strategy, spare parts inventory and assess areas for continuous improvement.
- Manage project timelines.
- Represent the Engineering group during facility pre-approval inspection audits.
QUALIFICATIONS, EDUCATION AND EXPERIENCE
- Bachelor’s degree in Mechanical Engineering, or similar field.
- A minimum of 7 years of experience in a biotechnology manufacturing environment.
- Knowledge of cGMP, FDA and other pharmaceutical regulatory requirements.
- Strong documentation skills in a cGMP environment.
- Experience in a computerized maintenance management system CMMS.
- Experience with large scale facility construction, fit out, and startup projects
- Experience with facility and equipment CQV activities
- Experience in operating and maintaining HVAC systems, heating hot water and chill water systems, gas systems, and other Bio/Pharm utility systems.
- Proven ability to maintain professional relationships with trusted design partners
- Strong ability to produce and review technical specifications
- Experience with decommissioning of processes or facilities
Preferred Qualifications:
- Proficient in CAD software.
- Experience in cGMP record review and regulatory audit participation.
- Knowledge of facility infrastructure
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