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Principal Engineer, MSAT

Company: iBio, Inc.
Location: Bryan
Posted on: June 12, 2021

Job Description:

Principal Engineer, MSAT

iBio is a global leader in plant-based biologics manufacturing. Our FastPharming System combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver gram quantities of high-quality monoclonal antibodies, vaccines, bioinks and other proteins. We accomplish all of this via our CGMP 130,000 square foot facility in Bryan, TX.

Just imagine what we can do together! We know great things happen when talent and opportunity cross paths. We are looking to hire exceptional people who have demonstrated track records of success. Our greatest scientific solution is bringing talented people together who have a passion for advancing plant-based biologics for our customers and the world.

Apply now for our Principal Engineer, MSAT position and help bring the power of plants to the biopharmaceutical industry!

Mission of the Position

As the Principal Engineer of Manufacturing Science & Technology (MSAT) you will have responsibilities for providing scientific and technical support to downstream bioprocess manufacturing operations. This role is responsible for managing tech transfer packages from Process Development to support the design, installation, commissioning, and validation of GMP processes and equipment.

Position Summary

The Principal Engineer, MSAT will be responsible for performing process monitoring and analysis, process performance troubleshooting, as well as establishment and maintenance of the process validated state and ongoing process improvement.

Essential Duties & Responsibilities

  • Manage team responsible for facility fit activities; including process flow diagram generation, scale-up calculations, defining equipment and solution requirements, generation bill of materials (BOM) and new specifications while ensuring safety and quality standards are maintained.
  • Provide technical expertise to lead process tech transfers through budget development, schedule development, resource planning, design, construction, commissioning, and qualification activities.
  • Provide technical expertise to lead the commissioning and validation of processes, process equipment and utilities.
  • Partner with Manufacturing, Process Development, Engineering, QA, QC, and Project Management to support the process transfer and project timelines.
  • Lead gap analyses and risk assessments to support the tech transfers.
  • Author tech transfer related projects plans, assessments, and process validation protocols
  • Authors and reviews process descriptions, formulations, batch records, bill of material, change controls.
  • Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and complex systems.
  • Works closely with manufacturing to provide on-the-floor technical oversight before and during GMP runs.
  • Review and approve vendor information packages, including drawings and specifications.
  • Provide key input into the validation of process equipment and associated utilities. Direct manufacturing and operations staff in the execution of validation protocols.
  • Assess all major deviations, identify potential root causes using a systematic approach. Expertise in use and application of variety of problem-solving tools. Able to identify potential solutions and lead multidisciplinary teams in developing and implementing solutions.
  • Recommends improvements for MSAT practices and procedures. Leads the compilation of process data, including communicating project status, and delivering presentations.

Knowledge, Skills, & Abilities

  • Excellent organization and time management skills.
  • Excellent communication skills, both written and verbal.
  • Use creativity and innovation to address urgent and/or complex problems and propose solutions.
  • Solid technical understanding of downstream processes (harvest, chromatography, TFF, and/or UF/DF)
  • Thorough knowledge of biopharmaceutical manufacturing, process equipment and supporting utility systems, especially those related to sterile operations
  • Process troubleshooting and experimental design
  • Prior experience in biologics manufacturing facility
  • Perform, understand, and interpret all types of complex data analysis such as multiple linear regression analysis, ANOVA, multivariate analysis and identify applications.
  • Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation.

Education & Experience

  • BS/MS/PhD in engineering discipline - Chemical Engineering, Biochemical Engineering, Biotechnology, Biochemistry, or related field.
  • 8+ years' experience in downstream biologics process development, technology transfer, pilot plant, or manufacturing support.
  • 8+ years applicable equipment and process system experience.
  • Extensive experience in biotech industry in process development, process scale up, tech transfer and manufacturing.
  • Experience in the design, installation, and operations of GMP processes and equipment.

Keywords: iBio, Inc., Bryan , Principal Engineer, MSAT, Other , Bryan, Texas

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