Live opening · Posted 15 hours ago

Technical SME & Project Lead

AbbVie · Westport, MO, Ireland
Smartrecruiters No Full-time
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At a glance

The key details from the original listing.

Posted 15 hours ago
CompanyAbbVie
LocationWestport, MO, Ireland
Job typeFull-time
Work modeNo
SourceSmartrecruiters
Listed15 hours ago

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About the role

Description supplied by the original job listing.

AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing team. In this role, you will provide technical expertise across manufacturing processes and technologies, supporting the introduction of new products and technologies, the optimization of existing operations, and the resolution of day-to-day technical challenges.
You will work closely with colleagues across Operations, Engineering, Quality, Validation, Technical Services, and other functions, as well as with AbbVie teams across the global network and external vendors and consultants.
This is an excellent opportunity for a technically minded professional with experience in biologics, pharmaceuticals, medical devices, or a related regulated manufacturing environment.
Key Responsibilities
Act as the Operations point of contact for site projects involving the introduction of new technologies or products and the upgrade of existing equipment and processes.
Provide technical support for day-to-day manufacturing queries, including support for change controls and CAPAs.
Lead or support process improvement initiatives focused on manufacturing reliability, efficiency, quality, and cost reduction.
Provide technical expertise for sterilization processes, including:
Filtration
Steam sterilization
Ethylene Oxide (ETO)
Gamma sterilization
Support manual and automated cleaning processes to ensure compliance with regulatory and quality requirements.
Provide technical support for depyrogenation processes and the effective removal of pyrogens from components.
Support lyophilization processes, including freeze-drying and vacuum-drying operations.
Provide technical expertise for Vaporized Hydrogen Peroxide (VHP) sterilization within cleanroom environments.
Support the design of facilities and utilities relevant to manufacturing processes, ensuring compliance and operational suitability.
Act as a technical authority for aseptic processing, including vial, cartridge, and syringe filling operations.
Contribute technical expertise to ongoing risk assessments and process evaluations.
Collaborate with cross-functional teams to implement innovative solutions that improve manufacturing performance and product quality.
Ensure new technologies and products meet applicable regulatory, quality, safety, and operational requirements and can be effectively integrated into existing processes.
Support departmental initiatives relating to safety, training, quality, and continuous improvement.
Participate in recruitment activities and relevant interview panels when required.
Travel occasionally to support project work and collaboration with other subject matter experts.
Required
A third-level qualification in a STEM discipline, or equivalent relevant experience.
Experience working in a biologics, pharmaceutical, medical device, or similarly regulated manufacturing environment.
Typically, 2–5 years of relevant experience in a technical or manufacturing role.
Strong understanding of regulatory requirements and industry standards relevant to aseptic manufacturing.
Demonstrated technical expertise and the ability to apply scientific and engineering principles to manufacturing challenges.
Strong communication and interpersonal skills, with the ability to work effectively in cross-functional project teams.
Ability to work independently, take initiative, define functional requirements, and deliver practical solutions.
Strong collaboration and team leadership skills, with the ability to work effectively across departments and organizational levels.
Preferred
Experience with aseptic filling operations for vials, cartridges, or syringes.
Experience with sterilization, cleaning, depyrogenation, lyophilization, or cleanroom technologies.
Experience supporting change controls, CAPAs, risk assessments, validation, or process improvement projects.
Experience working with external vendors, consultants, and global technical teams.

Employment type
Full-time

Work arrangement
No

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