Technical Services Engineer/Scientist
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| Job Type | Contractor |
| Location | Westmeath |
| Area | Westmeath, Ireland |
| Sector | EngineeringLaboratory/Scientific |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 1002935 |
| Job Views | 110 |
- Description
- Team Horizon is seeking a Technical Services Engineer/Scientist - Fill Finish for our client who are a global leader in the biopharmaceutical industry. This position will support the client’s midlands-based fill finish facility, where you will provide expertise to support all aspects of the manufacturing of commercial and future late-stage clinical products.
Why you should apply:
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.
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
What you will be doing:
Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and future late stage clinical products at the Facility.
Support technology transfers of new products into the Facility.
Lead troubleshooting efforts and deviation investigations in conjunction with internal partners (Process Development, Manufacturing, and Quality etc.).
SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure.
Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
Technical review of change controls for impact to product quality, safety and efficacy.
Provide on-floor technical support and troubleshooting.
Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
Collection, organisation, trending, and analysis of GMP manufacturing data.
Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
Support establishment of validation plans and evaluation of drug substance/product production site options.
Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated in the facility.
Any other duties as assigned.
What you need to apply:
Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices.
Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).
