Process Engineer, Person-In-Plant

Valid8 Financial, Inc.; Houston (TX); On-site; USD 70,000 - 110,000; Full time

Job summary

Join a pioneering biotechnology company dedicated to developing innovative T cell therapies for autoimmune diseases. As a Process Engineer, you'll play a crucial role in ensuring the reliability and optimization of manufacturing processes at Contract Development and Manufacturing Organizations. Collaborate with cross-functional teams to drive improvements and support training initiatives. This position offers the opportunity to contribute to groundbreaking therapies while advancing your career in a supportive and growth-oriented environment. If you're passionate about making a difference in patients' lives and thrive in a fast-paced setting, this role is perfect for you.

Qualifications

• Experience with cell processing equipment and Lean/Six Sigma methodologies.
• Strong communication skills and ability to manage multiple projects.

Responsibilities

• Provide oversight of CART drug product manufacturing at CDMOs.
• Support continuous improvement and troubleshooting during manufacturing.

Skills

Lean Manufacturing Principles

Process Validation

Troubleshooting Skills

Communication Skills

Project Management

Education

Bachelor's Degree in Engineering or related field

Tools

CliniMACS Prodigy

Sepax C-Pro

LOVO Cell Processing System

Xuri Bioreactor

Excel

Job description

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompasses two strategies: the CARTA (chimeric antigen receptor T cells for autoimmunity) strategy, with CABA-201, a 4-1BB-containing fully human CD19-CAR T, as the lead product candidate being evaluated in the RESET (REstoring SElf-Tolerance) clinical trials in systemic lupus erythematosus, myositis, systemic sclerosis and generalized myasthenia gravis, and the CAART (chimeric autoantibody receptor T cells) strategy, with multiple clinical-stage candidates, including DSG3-CAART for mucosal pemphigus vulgaris and MuSK-CAART for MuSK myasthenia gravis. The expanding CABA platform is designed to develop potentially curative therapies that offer deep and durable responses for patients with a broad range of autoimmune diseases. Cabaletta Bio’s headquarters and labs are located in Philadelphia, PA.

At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved.

About the Position

The Process Engineer, Person-In-Plant is responsible for supporting ongoing clinical and future commercial manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs), ensuring process reliability and optimization within our operations. The ideal candidate will work closely with cross-functional teams, including Manufacturing, Quality, Process Development, and Supply Chain, to drive continuous improvements in manufacturing performance. Travel Requirement: Must be willing to travel to corporate headquarters in Philadelphia for continuous training within the first 6 months.

Responsibilities:

• Provide “Person-in-Plant” (PIP) support and oversight of CART drug product manufacturing activities at Contract Development and Manufacturing Organizations (CDMOs)
• Possess in-depth knowledge of the manufacturing process, including critical process parameters, risks and provide technical oversight and guidance
• Serve as a communication bridge between the Cabaletta and the contract manufacturer, address concerns, escalate issues, and provide timely updates.
• Real-time troubleshooting of issues that arise during manufacturing.
• Support CDMO manufacturing operator training program.
• Lead manufacturing related deviation investigations and CAPAs across the network.
• Establish network business process for root cause analysis using established methodologies.
• Support data capture of manufacturing production through excel and other data software.
• Perform comprehensive manufacturing data analysis and trending.
• Identify and support continuous improvement efforts between Cabaletta and the CDMO.
• Review of batch records and other documentation to support product release activities.
• Support drafting documentation that will be supplied to the CMO which includes but not limited to: Batch Records, Work Instructions, forms and Memos.
• Support and review CDMO documentation from draft to finalization.
• Support any pre-clinical runs which could include verification runs, pilot runs and engineering runs at the CDMO.
• Ability to work off-shift, weekends and long hours as needed.

Qualifications:

• Experience of using cell processing related equipment, such as CliniMACS Prodigy, Sepax C-Pro, LOVO cell processing system, and Xuri bioreactor.
• Familiarity with Lean and Six Sigma methodologies.
• Strong understanding and application of Lean manufacturing principles.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Experience of process validation lifecycle approach and risk assessments using a variety of tools, e.g., FMEA.
• Highly organized and efficient, strong team orientation and passion for continuous self-development.
• Ability to manage and coordinate parallel tasks across multiple projects, prioritize multiple tasks and ensure completion in a timely manner while working within a fast-paced environment.
• Experience contributing to preparation of documents for regulatory review, including but not limited to, INDs and BLAs.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.