Process Engineer II

Job Overview
The Process Engineer will work in the Manufacturing Science and Technology (MSAT) group to provide technical support to clinical operations at the Philadelphia, PA site. The responsibility of this role is to support cell and gene therapy production.
MSAT is responsible for:
· Leading the introduction of new manufacturing processes to facility clinical and commercial manufacturing of drug substance for biologics and/or nucleic acids.
· Performing technology transfer from the development laboratory into all phases of GMP manufacturing.
· Supporting process investigations, equipment and process troubleshooting.
· Identifying and driving implementation of improvements to maximize throughput and capacity utilization.
· Defining relevant operational/technical standards and practices for the site.
· Providing support and content for regulatory submissions
The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.

Job Responsibilities

· Provide technical support to GMP operations in a multi-product and multi-modality facility including both cell and gene therapies.

· Function as a technical resource for the resolution of deviations, investigations, and process issues. Complete technical investigations and provides on the floor technical expertise.

· Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc.

· Actively participate in client meetings and serve as a technical SME.

· Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques (e.g., excel, JMP, etc.).

· Routinely troubleshoot operational issues for process related operations.

· Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs.

Process Design for Scale-up to Manufacturing

· Provide technical leadership for execution of engineering runs during technology transfer from development to manufacturing.

· Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables.

· Perform statistical analysis.

· Respond to and trouble-shoot process issues related to assigned work and areas of expertise.

· Assess and select equipment to meet process needs.

· Perform material assessments as required.

· Develop scientific and technical understanding of unit operations and production processes.

Technology Transfer to GMP Production

· Participate in technology transfer activities and provide oversight of GMP runs to support technology transfer to production.

· Perform key project deliverables for technology transfer activities for new client projects.

· Define and justify critical and key process parameters.

· Participate in the development of specifications, standard operating procedures, work instructions and forms to support implementation of new processes.

· Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.

· Perform and/or support risk assessment activities including hazard and operability studies.

· Train production staff to ensure they can perform duties involving new equipment and new processes.

· Generate protocols and reports for engineering, and clinical GMP runs.

· Prepare change controls and perform change control assessments according to internal procedures as required.

· Comply with safety requirements and work to resolve any environmental, health and safety issues.

· Optimize processes to effectively and efficiently produce product that meets clients’ quality specifications.

Basic Qualifications
· BS or MS in Chemical Engineering/Biological Engineering/Biology or related disciplines with excellent understanding of biotechnology processes
· Embodies the Resilience phenotypes of grit, quality + rigor, service orientation, EQ+IQ, builder mentality, velocity, and ownership.
· Demonstrated technical, operational, and/or hands-on equipment knowledge of cell / gene therapy, and process data analysis.
· Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
· Understanding of quality, compliance, regulatory, and good manufacturing practices.
· Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and multiple stakeholders.
· Ability to influence others without direct authority and communicate with all levels of the organization.
· Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.

Preferred Qualifications
· M.S./B.S. in Life Sciences, Chemical or Biological Engineering, or related discipline with 3-5 years of relevant industry experience in process development, technology transfer, or GMP Manufacturing.
· Experience in the scale up and operation of cell / gene therapy manufacturing practices.
· Experience developing acceptance criteria for technology transfer
· Hands‐on experience cell and/or gene therapy biotechnology unit operations.
· Experience with single use technology and systems.
· Experience working for or with contract manufacturing organizations.
· Experience owning, managing, and executing change controls and using management systems (ex. Veeva).

Additional Requirements
· On site work required for position
· Support 24/7 production/manufacturing activities, which may require off-shift work on occasion including weekends.
· Ability to gown.

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