Principal Engineer, MSAT
Company: iBio, Inc.
Posted on: June 12, 2021
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
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
- 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
- Lead gap analyses and risk assessments to support the tech
- 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
- 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
- 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
- 8+ years' experience in downstream biologics process
development, technology transfer, pilot plant, or manufacturing
- 8+ years applicable equipment and process system
- Extensive experience in biotech industry in process
development, process scale up, tech transfer and
- 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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