Manager, Process Engineering

The Role:

ElevateBio is looking to hire a Manager Process Engineering at BaseCamp® Pittsburgh. The Manager Process Engineering will be responsible on aspects of introducing a new suite of Cell & Gene Therapy (CGT) products at our development and manufacturing site.  The role is involved in onboarding new process equipment, working closely on the ground with production personnel, supports process equipment commissioning and qualification, organize the production process equipment layout, and coordinates with other departments on ensuring the validated status of process equipment. The Manager Process Engineering manages the equipment lifecycle, troubleshooting activities for the BaseCamp® facility, utilities, and equipment. This role provides 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:

• 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.

Requirements:

• 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.
• Experience in Cell Cultures/Viral Vectors experience is a plus.
• 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.