Process Engineer

Title: Process Engineer

Report: Facilities Manager

Location: Philadelphia, PA

Position Type: Full Time, Exempt

Travel: Occasional (0-10%)

Company Summary

VintaBio is a technology company focused on simplifying AAV and lentivirus production. Our custom research and development approach is designed to integrate into services, including platform bridging, GLP toxicology material, and GMP manufacturing. Our research core produces high-yield and world-class POC vectors. Through a comprehensive production workflow that utilizes VintaBio's proprietary cell lines and transfection reagents, we expedite the path to the clinic, offer more reliable manufacturing, and improve economics.

Position Summary

The Process Engineer will support the optimization and scale up of existing processes, investigations into new technologies, and introduction of new process equipment. The Process Engineer will play a pivotal role in transitioning research and development processes to GMP manufacturing. The Process Engineer will apply best practices and GMP knowledge in CGT development and manufacturing to improve and scale up processes. They will be involved with projects from the inception of user requirements through the introduction and validation of equipment, including supporting troubleshooting and future optimization. The Process Engineer may also support facility development and assisting with the management of facilities maintenance and calibration - especially around new single use technologies.

Key Responsibilities

To perform in this position successfully, an individual must be able to perform each key responsibility satisfactorily. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Other duties may be assigned to meet business needs.

Essential Job Functions

• Trouble shooting and optimization of existing processes to increase capacity and capability while decreasing complexity and cost.
• Working with MSAT to develop user requirements for new systems.
• Performs risk assessments for new processes and equipment.
• Prepares process flow diagrams and mass balances to support process development activities.
• Evaluating existing facilities to support future technologies.
• Stays current on new technologies and recommends evaluation of such technologies.
• Write specifications and scope of work documents for new process systems, single-use process equipment and manifolds, and facilities modifications for new equipment.
• Performing technical and commercial bid evaluations and recommending vendors and contractors.
• Perform investigations.
• Prepares economic business cases for new technology
• Prepares change controls for facilities and process equipment modifications and equipment introduction.
• Manages outside consultants for engineering, facilities, commissioning, qualification and calibration work.
• Updates the site CMMS system for preventative and on demand maintenance, calibration and qualification activities.
• Support and/or develop and execute commissioning and qualification of facilities, process and lab equipment.
• Create, write, and review Standard Operating Procedures and work instructions to illustrate process and lab system/equipment procedures.
• Maintains digital copies of all applicable publications on the server related to the process systems installed in the facility.
• Assists with keeping the building drawings up to date.
• May respond to inquiries, provide help or guidance to anyone requiring assistance.
• Other related duties as assigned.

Education and Experience

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or other related science or engineering field required.
• Minimum of 5-10 years' experience of sterile drug manufacturing experience, preferably in process development or engineering of ATMPs/CGT equipment and processes.

Knowledge, Skills and Abilities

• Ability to work flexible work schedules.
• Possess and demonstrate exceptional problem-solving skills.

• Must be able to read, write and understand English fluently.
• Satisfactory computer, verbal, and written communication skills.
• Proficient in Microsoft Excel, Word, Projects, PowerPoint and Visio.
• Proficient in Adobe Software.
• Experience in AutoCAD is desirable. Able to understand and draw PFDs and P&IDs.
• Familiarity of Facilities Management applications including Computerized Maintenance and Management Systems (CMMS) and Building Automation systems (BAS) is a plus.
• Experience with Quality Management Systems (QMS) is a plus.
• Ability to work in a team environment and independently as required.
• Ability to prioritize multiple demands.

Work Environment and Physical Requirements

• Must be able to work in a lab setting, downing the required PPE for the use of various chemicals and biohazards.
• Must be able to work in an open-office environment.
• Must be able to pass gown qualification to work in an ISO-7 environment.