Technical SME & Project Lead

ABBVIE; Waterford; On-site; EUR 70,000 - 110,000; Full time

Job summary

AbbVie is seeking a Technical SME & Project Lead to join the Core 1 Manufacturing team. You will provide technical expertise across manufacturing processes and technologies, supporting new products and technologies, and optimizing existing operations.

You will collaborate with Operations, Engineering, Quality, Validation, Technical Services, and external vendors to resolve day-to-day technical challenges in a regulated environment.

Qualifications

• Third-level STEM degree or equivalent experience.
• Experience in biologics/pharma/medical devices regulated manufacturing.
• 2–5 years in a technical or manufacturing role.
• Strong regulatory and quality assurance awareness.

Responsibilities

• Act as Operations point of contact for site projects introducing new technologies or products.
• Provide technical support for day-to-day manufacturing queries incl. change controls and CAPAs.
• Lead or support process improvement initiatives for reliability, efficiency, quality and cost.
• Provide technical expertise for sterilization processes (Filtration, Steam, ETO, Gamma).
• Support cleaning processes to ensure regulatory and quality compliance.
• Provide technical support for depyrogenation to remove pyrogens.
• Support lyophilization processes (freeze-drying, vacuum-drying).
• Provide technical expertise for VHP sterilization in cleanrooms.
• Assist in facility and utility design for manufacturing processes.
• Act as technical authority for aseptic processing (vials, cartridges, syringes).
• Contribute to risk assessments and process evaluations.
• Collaborate with cross-functional teams to implement innovative manufacturing solutions.
• Ensure compliance of new technologies with regulatory, quality, safety requirements.
• Support departmental initiatives on safety, training and continuous improvement.
• Participate in recruitment and interview panels as needed.
• Occasional travel to support project work with external experts.

Skills

STEM degree

Regulated manufacturing experience

2–5 years experience

Regulatory knowledge

Cross-functional collaboration

Project leadership

Excellent communication

Education

STEM qualification

Job description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

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.

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,2–5 years of relevant experiencein 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.

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.