Process Engineer II, MSAT

8 hours ago

West Norriton, Pennsylvania, United States Resilience Corp. Full time
Job Summary

The Process Engineer will work in the Manufacturing Science and Technology (MSAT) group to provide technical support to CMP Manufacturing operations at the Philadelphia, PA site. The responsibility of this role is to support cell therapy production. This is a site-based role in East Norriton, PA.

Key Responsibilities
  • Leading the introduction of new manufacturing processes to the facility for clinical and commercial manufacturing of cell therapy products.
  • Performing technology transfer from the development laboratory into all phases of GMP manufacturing.
  • Supporting the design, test, and qualification of MES recipes for electronic batch records.
  • 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.
  • Ensuring manufacturing processes are capable, compliant, in control, and continuously improved.
Requirements
  • 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 with digital Manufacturing Execution Systems (MES).
  • Experience owning, managing, and executing change controls and using management systems (ex. Veeva).
About Resilience Corp.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

At Resilience, we're committed to creating a workplace that's inclusive, diverse, and supportive of all employees. We offer a comprehensive benefits package, including equity, an annual cash bonus program, a 401(k) plan with a generous company match, and more.

Our target base pay hiring range for this position is $75,000.00 - $101,250.00 per year. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate's geographical location, relevant experience, qualifications, skills, and knowledge.

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