Senior Facilities Engineer
2 days ago
We are seeking a highly skilled Senior Facilities Engineer to join our team at Vericel Corporation. This role will be based full-time in our new, state-of-the-art facility located in Burlington, MA. The successful candidate will be responsible for supporting the startup, troubleshooting, commissioning, qualification, and engineering lifecycle initiation of manufacturing equipment, utilities, and the facility.
Key Responsibilities- 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.
- Serve as a subject matter expert (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 the 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.
- Bachelor's degree in Mechanical Engineering or a 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.
- Proficient in CAD software.
- Experience in cGMP record review and regulatory audit participation.
- Knowledge of facility infrastructure.
Vericel Corporation is an Equal Opportunity/Affirmative Action Employer. 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.
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