Process Validation Engineer Job In Brisbane, California, Katalyst Healthcares & Life Sciences

Published 2022-08-10
Expires 2022-09-10
ID #1121186633
Process Validation Engineer Job In Brisbane, California, Katalyst Healthcares & Life Sciences
United States, California, Brisbane,
Published August 10, 2022

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Per annum
Occupation: Process validation engineer

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The candidate will be responsible for assessing, strategizing, developing, implementing, and supporting end-to-end DP infrastructure and processes based on the facility and product needs.

This includes assessment of Client production facilities and tools such as modular DP filling, single use systems and components, ready-to-use primary packaging systems, small-scale models for process design, characterization, and validation, and process analytical capabilities to enable a robust facility and process for clinical DP production.

We are looking for a candidate who is versed with the latest technological developments and insights in the cell and gene therapy manufacturing industry.


Roles & Responsibilities:

Work closely with other engineers (site, mechanical, structural, electrical, chemical etc) to assess, install, qualify, and verify/validate a modular DP filling system with associated DS compounding and filtration containers and components

Collaborate with the downstream process development group to ensure a smooth transition from purification and final formulation production steps to fill and finish activities

Design and execute process development, characterization, and validation studies to support fill/finish infrastructure and process requirements to support the production of pipeline genomic medicinal products for clinical supply and resupply

Lead scale up and technology transfer of products across internal and external manufacturing sites.

Author, review functional and cross-functional process characterization/validation protocols, multivariate studies, reports and drive timely execution with quality oversight

Provide on-going fill-finish manufacturing support including MAR support, process capability analysis, and impact assessments during quality investigations to ensure product and process health

Lead teams to generate production SOPs and other related guidance documents and templates

Contribute to the compilation and review of master batch/production records, change controls, standard operating procedures, and guidance documents

Author regulatory section in support of investigation new drugs (IND) and marketing application submissions

Provide strategic guidance to the team in leveraging QbD tools & RRF strategy to take informed risk and accommodate accelerated timelines

Education & Experience:

Ph.D. in chemical or biomedical engineering, pharmaceutical sciences, biochemistry, or related discipline and a 2+ years' experience in industry 9Will consider BS/MS with 6+ years of experience.  Level will be dependent on educations., skills and experience.

Experience in the assessment, installation, and qualification of DP production equipment and associated consumables and components following cGMP requirements

Experience in designing and qualification of unit operations such as freeze/thaw, pooling/mixing, filtration, filling, capping, visual inspection, packaging etc. 

Experience with biopharmaceutical product and process development, process-engineering, aseptic fill/finish operations and cGMP knowledge.

Experience in QbD methodologies and statistical analysis using JMP or Minitab.

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    Employer's info

    Katalyst Healthcares & Life Sciences
    Registered on October 7, 2017


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    Manufacturing is the production of merchandise for use or sale using labour and machines, tools, chemical and biological processing, or formulation. The term may refer to a range of human activity, from handicraft to high tech, but is most commonly applied to industrial production, in which raw materials are transformed into finished goods on a large scale. Such finished goods may be sold to other manufacturers for the production of other, more complex products, such as aircraft, household appliances, furniture, sports equipment or automobiles, or sold to wholesalers, who in turn sell them to retailers, who then sell them to end users and consumers.

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