Senior Process Engineer
About The Position
ElevateBio is looking to hire a Senior Process Engineer to join the Process Engineering team at BaseCamp. The Senior Process Engineer will lead the equipment lifecycle management, troubleshooting activities for the BaseCamp facility, utilities, and equipment. The Senior Process Engineer will provide technical and process support for the manufacturing suites on site working facilities, engineering, process development, manufacturing, and Quality Control and Quality Assurance (QA) teams. Here’s What You’ll Do: 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
Requirements
- 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.
Nice To Haves
- Experience in Viral vector & Cell/Gene Therapies experience is a plus
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
