Senior Process Engineer

The Role

Elevate Bio is looking to hire a Senior Process Engineer to join the Process Engineering team  Senior Process Engineer will lead the equipment lifecycle management, troubleshooting activities for the Base Camp facility, utilities, and equipment. The role provides technical and process support for the manufacturing suites on site, working with facilities, engineering, process development, manufacturing, and Quality Control and Quality Assurance (QA) teams.

• 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 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 the impact of changes to implemented processes and mitigate 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 overall process engineering milestones.
• Support equipment efficiency review and revalidation activities.
• Oversee external contractors and vendors during troubleshooting efforts.
• Ensure discrepancies are resolved and closed out to meet project timelines.

• A minimum of 8 years of experience in GMP biotech engineering or an FDA-regulated manufacturing facility.
• BS degree in engineering or equivalent experience.
• Experience in cGMP facility/equipment start-up, processing, and qualification.
• Experience with good documentation practices and cGMP standards.
• Ability to work on multiple tasks simultaneously and manage priorities, deliverables, and schedule milestones.
• Strong interpersonal, verbal communication, and technical writing skills.
• Experience in cGMP processes including upstream cell expansion, downstream purification, and fill finish.
• Experience in viral vector and cell/gene therapies is a plus.

Salary range: $150,000 - $200,000. This range is a good faith estimate of the expected salary range based on qualifications, experience, and needs.

Elevate Bio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The Elevate Bio ecosystem combines multiple R&D technology platforms with Base Camp, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

We seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.

Elevate Bio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to race, color, gender, age, religion, national origin, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Elevate Bio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.