ElevateBio · 3 hours ago
Manager, Process Engineering
Pittsburgh, PA
Full-time
Onsite
Senior Level
6+ years expElevateBio is a technology-driven cell and gene therapy company focused on advancing the future of medicine through innovative technologies. The Manager of Process Engineering will oversee the introduction of new Cell & Gene Therapy products, manage process equipment, and ensure operational efficiency while collaborating with various teams to support manufacturing processes.
BiotechnologyGeneticsLife ScienceTherapeutics
Responsibilities
Ensure that the process standards, procedures and specifications are in place for new assets
Manage resources to support operations of process systems, GMP operations, production equipment, New Process Introductions, and Process fit
Develop process maintenance system based on risk and reliability management principle
Develop process engineering initiatives to manage engineering project implementation, ensures compliance through the system life cycle
Recruit, train and direct resources to improve total performance and productivity, includes appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for direct reports
Work with other departments and teams to ensure optimum levels of operability and maintainability, in on-the-floor troubleshooting, resolving automation, technical and/or process issues
Understand change management throughout the asset and process lifecycle to mitigate risks through process review cycles, evaluate process flows and provide recommendations
Plan organizational and technical strategies impacting budget, staffing, goals, and culture
Analyze and develop engineering solutions to maintenance, continuous improvement, quality and safety initiatives, and failure investigations for process systems and instrumentation
Work within manual and electronic Engineering Documentation Systems to maintain engineering drawings and equipment history files
Understand the capability of the equipment, programming, and services used within production
Serve as a point of contact for technical support for Manufacturing and Engineering for process equipment issues
Provides equipment support for other Engineering functions including Maintenance, Validation, and Capital Engineering
Author and provide technical support for discrepancies, deviations, and/or CAPAs
Support equipment efficiency review and revalidation activities
Qualification
Required
6+ years of experience in GMP biotech engineering or an FDA regulated manufacturing facility
2+ years of management leadership/supervisory experience in hiring, building, training, and leading high-performance teams
BS degree in a related Engineering field in Biotech/Pharmaceuticals
Experience in cGMP facility/equipment start-up, processing, and qualification
Required experience with good documentation practices and cGMP standards
Experience in cGMP processes such Cell Therapy, Gene Therapy, and/or mRNA production
Requires strong technical writing skills with experience writing Requirement Specifications (Design, Functional, User), FMEAs, FAT/SAT/Commissioning Protocols, SOPs and Work Instructions. Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment
Requires strong interpersonal and verbal communication
This position requires a professional who will be expected to perform tasks autonomously at times; minimum supervision required on day-to-day activities and accomplished tasks
Will be required at times to lead engineering projects from start to finish including documentation, scheduling, overseeing maintenance mechanics and/or contractors
Preferred
Experience in Cell Cultures/Viral Vectors 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 (15)
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