Technical SME & Project Lead

AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing 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.

Qualifications :

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 25 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.

Additional Information :

What You Will Bring

You will be a proactive solutions-focused professional who can combine strong technical knowledge with practical manufacturing experience. You will be comfortable working in a regulated environment managing multiple priorities and communicating effectively with stakeholders at all levels.

About AbbVie

AbbVie is a global research-driven biopharmaceutical company committed to discovering and delivering innovative medicines and solutions that address complex health challenges. Our culture is built on collaboration scientific excellence integrity and a commitment to improving patients lives.

AbbVie is an equal opportunity employer. We value diversity and are committed to creating an inclusive workplace where everyone can contribute grow and succeed.

Apply today to join the Core 1 Manufacturing team as a Technical SME & Project Lead

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time