ElevateBio · 2 hours ago
Senior Process Engineer
Waltham, MA
Full-time
Onsite
Senior Level, Lead/Staff
$150K/yr - $180K/yr
8+ years expElevateBio is a technology-driven cell and gene therapy company, accelerating access to cutting-edge technologies to change the future of medicine. The Senior Process Engineer will lead equipment lifecycle management and provide technical support for manufacturing suites, ensuring compliance and efficiency in operations.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
Provide in-depth knowledge of GMP operations, production equipment, New Process Introductions, and Process fit
Serve as an SME for production equipment and responsible for on-the-floor troubleshooting
Proactively identify and remediate automation, technical and/or process issues team and solving issues with minimal guidance
Manage and report the capability of the equipment, programming, and services used within production
Serve as the primary contact for technical support for Manufacturing and Engineering for any process equipment issues
Understand impact of changes to implemented processes and mitigates risks through process review while remaining compliant
Apply technical expertise to cross-functional teams to provide input and recommendations for improvements while remaining compliant
Provide equipment support and expertise in other Engineering functions including Maintenance, Validation, and Capital Engineering
Author and provide technical expertise for discrepancies, deviations, and/or CAPAs
Lead process initiatives and deliverables to meet the overall process engineering milestones
Support equipment efficiency review and revalidation activities
Oversee external contractors and vendors during any troubleshooting efforts
Ensure discrepancies are resolved and closed out to meet project timelines
Qualification
Required
A minimum of 8 years of experience in GMP biotech engineering or an FDA regulated manufacturing facility
BS degree in engineering field or equivalent experience
Experience in cGMP facility/equipment start-up, processing, and qualification
Required experience with good documentation practices and cGMP standards
Ability to work on multiple tasks simultaneously
Ability to manage priorities, deliverables, and schedule milestones
Requires strong interpersonal, verbal communication, and technical writing skills
Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish
Preferred
Experience in Viral vector & Cell/Gene Therapies experience is a plus
Company
ElevateBio
ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (19)
2023 (17)
2022 (6)
2021 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
Company data provided by crunchbase