Job Description - SNFIJP00006678 - USA-Process Engineer III (Engineering) in Swiftwater
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SNFIJP00006678 - USA-Process Engineer III (Engineering)

Ref: US_EN_6_971649_1457765

Posted on 28 July 2022

A Process Engineer job in Swiftwater, Pennsylvania is available through Modis. This is a long-term W2 contract position that is onsite in Swiftwater, PA.

This Process Engineer will be supporting manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at client industrial sites. This position develops process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions in IO to deliver following:

Responsibilities:

  • Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
  • Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
  • Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment
  • Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
  • Behaves according to company values and competencies.
  • Forward thinking with an attitude of collaboration, optimization, efficiency, continuous improvement.
  • Effectively communicates successes, constraints, conflicts, solutions and actions for resolution.
  • Proactively resolves conflicts, removes roadblocks to execution within sphere of influence; escalates to functional management when appropriate.
  • Fosters relationships with partners and customers in order to achieve technical objectives.
  • Basic Qualifications:

  • BS in Chemical or Biochemical Engineering (or similar) with a minimum of 7 years industrial experience.
  • Experience with large scale process equipment design, scale-up implementation & validation experience.
  • Biologics experience or pharmaceutical experience.
  • Technical writing experience.
  • Hands on equipment experience (IQ/OQ/PQ).
  • Preferred Skills:

  • Expertise in one or more upstream process unit operation design typically used in biotech / vaccine manufacturing (seed expansion, viral growth and egg processes, harvest / clarification) as well as project / engineering lifecycle;
  • Knowledge of computer software common to mission (AutoCAD, process simulation / scheduling, CFD) is preferred.
  • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
  • Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
  • Experience in equipment start-up, qualification and validation is preferred.
  • Equal Opportunity Employer/Veterans/Disabled

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    The Company will consider qualified applicants with arrest and conviction records

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