Manufacturing Process Specialist

About AbbVie

AbbVie is devoted to creating innovative medicines and solutions that tackle serious health challenges now and in the future. Our impact spans critical therapeutic fields such as immunology, oncology, neuroscience, as well as products within our Allergan Aesthetics portfolio.

Role Overview

Join AbbVie’s dynamic team in Ballytivnan, Sligo, as a Manufacturing Process Specialist focusing on Antibody Drug Conjugation (ADC). This position offers an exciting opportunity to lead technical support and enhance manufacturing operations, particularly in process development and equipment qualification.

Primary Responsibilities

• Act as a subject matter expert in formulation, aseptic filling, and isolator technologies.
• Represent manufacturing operations during regulatory audits.
• Own comprehensive knowledge of manufacturing equipment, processes, and technologies.
• Manage sourcing and procurement of process equipment with technical oversight.
• Provide ongoing technical support for process and equipment-related activities.
• Collaborate with network experts to ensure consistent practices and technical excellence.
• Design and execute technical studies supporting investigations and product improvements.
• Develop expertise in new pharmaceutical manufacturing techniques.
• Initiate and lead continuous process improvement projects focusing on performance enhancement and cost efficiency.
• Define process parameters, controls, and equipment performance specifications.
• Implement statistical process controls and analyze manufacturing process data.
• Oversee end-to-end technology transfer projects including planning, execution, and reporting.
• Support new product and process introductions.
• Lead root cause analysis and corrective actions for manufacturing deviations.
• Develop and update procedures to support operational needs.
• Participate in validation activities related to processes, equipment, and facilities.
• Coordinate with operations, quality assurance, and science & technology teams to optimize performance.
• Ensure compliance with quality and safety standards.
• Manage successful completion of external inspections and audits.
• Supervise activities of external contractors as required.

Qualifications & Experience

• Minimum level 8 qualification in engineering, science, or a technical discipline.
• At least three years’ experience in pharmaceutical process engineering, including batch processing, technical transfers, scale-up, commissioning, and validation within cGMP pharmaceutical or biologics environments.
• Proven expertise in process validation compliant with US and EU market regulations.
• Strong history of delivering results and high-quality technical writing skills.
• Experience leading complex investigations.
• Advanced technological proficiency relevant to pharmaceutical manufacturing.
• Solid understanding of FDA and EU quality systems as they apply to manufacturing, facilities, and process engineering.
• Desirable: experience with new product introductions and lean manufacturing methodologies.
• Preferable prior exposure to lyophilization and sterilization operations.
• Demonstrated project management capabilities, successfully delivering projects on time, within budget, and according to quality expectations.

Additional Information

AbbVie is an equal opportunity employer committed to integrity, innovation, community service, and diversity. We strongly encourage applicants from all backgrounds, including veterans and persons with disabilities. The company abides by applicable quality and safety policies and welcomes accommodations for applicants as appropriate.