Technical Services Engineer Fill Finish

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  This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


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  Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.

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  Deliver significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late-stage clinical products.


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  Support technology transfers of new products.


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  Manage troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).


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  Act as a subject matter expert for the introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.


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  Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.


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  Technical review of change controls for impact to product quality, safety and efficacy.


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  Provide on-floor technical support and troubleshooting.


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  Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.


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  Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.


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  Collection, organisation, trending, and analysis of GMP manufacturing data.


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  Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.


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  Support establishment of validation plans and evaluation of drug substance/product production site options


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  Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process

 

 

What you need to apply:

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  Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.


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  Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.


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  Skilled in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.


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  Complete understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices


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  Knowledge of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.


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  Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.


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  Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).