Senior Technical SME & Project Lead, Biologics Operations

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 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.