Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Вакансия дает серьезную практическую ответственность в крупной биотех-компании, но широкий охват производства субстанции и упаковки, работа только на площадке и возможные дежурства или смены снижают гибкость.
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Широкий круг задачВозможны дежурстваКрупная биотех-компанияПонятные требованияТолько работа на площадке
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Описание вакансии
Текст:
Hirify AI/Оригинал
TL;DR
MSAT DS Engineer III & Packaging (Biotechnology): Supporting drug-substance manufacturing, technology transfer, validation, labeling, packaging, final storage, and lifecycle CMC activities at Moderna’s Oxford site with an accent on cGMP execution, process monitoring, and technical documentation. Focus on designing disposable bioprocessing systems, troubleshooting manufacturing and packaging equipment, executing qualification studies, and applying approved Generative AI within GxP and data-integrity controls.
Location: Oxford, England, United Kingdom; 100% onsite with flexibility for on-call coverage and/or shift working when required.
Company
hirify.global develops mRNA medicines and operates research, laboratory, and manufacturing activities at its Harwell site in the United Kingdom.
What you will do
Manage technology transfer, process start-up, validation, commercial cGMP manufacturing, continued process verification, and lifecycle CMC activities for drug-substance products.
Develop, review, and execute protocols; oversee manufacturing studies and executions; interpret performance data; and author technical reports.
Lead troubleshooting, process monitoring, investigations, CAPA, equipment scale-up, and continuous-improvement activities across manufacturing operations.
Design moderately complex disposable bioprocessing systems, including aseptic bags and tubing manifolds, and execute equipment-fit and process-performance studies.
Support packaging, labeling, cartoning, final-storage, commissioning, qualification, technical documentation, audits, and quality issue resolution.
Collaborate with Manufacturing, Quality, Supply Chain, Regulatory, F&E/CQV, Process Experts, and Technicians while maintaining GxP, GMP, documentation, data-integrity, and safety requirements.
Requirements
B.Sc. or M.Sc. in Biochemical Engineering, Chemical Engineering, Biotechnology, Biochemistry, or a related field, or equivalent relevant industry experience.
Typically 6+ years of relevant pharmaceutical or biotechnology experience with a B.Sc., or 3+ years with an M.Sc.; equivalent practical industry experience may also be considered.
Ability to follow GMP regulations, GxP requirements, company policies, standard operating procedures, work instructions, Good Documentation Practices, and Data Integrity requirements.
Ability to complete required training and requalification within defined timelines and maintain safe work practices.
The role may require an enhanced pre-employment check.
Nice to have
Process development or operational experience with enzymatic reaction, chromatography, tangential flow filtration, buffer formulation, drug-product formulation, or aseptic filling.
Technical-support experience in cGMP manufacturing, including single-use consumables, stainless-steel tanks, and skids.
Experience with technology transfer, change control, investigations, data analysis, drug formulation, filling processes, labeling, and packaging.
Outstanding verbal and written communication skills.
Ability to manage projects in a fast-paced environment and collaborate effectively in a dynamic, cross-functional matrix.
Ability to adapt to new and challenging technical opportunities.
Culture & Benefits
In-person, site-based working model focused on physical collaboration, mentorship, and hands-on manufacturing support.
Healthcare and voluntary benefit programs, fitness, mindfulness, and mental-health support.
Family-building benefits, including fertility, adoption, and surrogacy support.
Paid time off including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Savings and investment programs plus location-specific benefits.
Approved Generative AI tools may be used for technical knowledge management, data interpretation, document development, and continuous improvement within applicable confidentiality, GxP, validation, and data-integrity controls.
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