Manufacturing Process Specialist - ADC & Tech Transfer

Allergan; Ireland; On-site; EUR 65,000 - 90,000; Full time

Job summary

AbbVie Ballytivnan (Sligo) seeks a Manufacturing Process Specialist to lead and support ADC manufacturing operations. You will own process equipment knowledge, collaborate on technology transfers, and drive continuous improvement from development through scale-up and validation.

Role involves creating SOPs, liaising with suppliers, and ensuring compliance with FDA/EU quality systems while contributing to cost reductions and process optimization across manufacturing lines.

Qualifications

• Minimum level 8 qualification in an engineering, science or technical discipline.
• At least three (3) years in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry.
• Specific experience in process validation to US/EU markets.
• Demonstrated experience of technical writing of complex issues.
• Must have experience in taking a lead role in investigations.
• High level of technology experience.
• Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities and process engineering.
• Experience in new product introductions is desirable.
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required.
• Experience working with lean methodologies is desirable.
• Previous experience in lyophilization and sterilization operations preferable

Responsibilities

• Serve as a SME in formulation, aseptic filling processes, and isolator technology.
• Represent the team at regulatory audits.
• Own manufacturing equipment, process knowledge, and technology.
• Source and procure process equipment with technical oversight.
• Provide technical support for manufacturing processes and equipment.
• Collaborate with technical experts across the network to ensure consistency and best practices.
• Design and implement technical studies and programs to support investigations and product improvements.
• Develop knowledge of new pharmaceutical manufacturing processes.
• Identify and manage continuous improvement projects.
• Drive process improvements for enhanced performance and cost reduction.
• Establish specifications for process parameters, process controls, and equipment effectiveness.
• Implement statistical process control systems.
• Monitor and analyze process data during drug product manufacturing.
• Oversee planning, execution, and reporting for technology transfer projects.
• Support the introduction of new products and processes.
• Lead root cause analysis and corrective actions for process deviations.
• Develop and modify procedures to support manufacturing operations.
• Participate in process, equipment, and facilities validation efforts.
• Liaise with operations, quality, and S&T to optimize equipment and process performance.
• Adhere to relevant quality and safety policies.
• Ensure successful external inspections and audits.
• Supervise external contractors.

Skills

Process engineering

cGMP

Process validation

Investigations

Lean methodologies

Technical writing

Project management

Lyophilization

Sterilization

Regulatory knowledge

Team leadership

Education

Bachelor's degree in engineering/ sciences

Job description

AbbVie Ballytivnan (Sligo) seeks a Manufacturing Process Specialist to lead and support ADC manufacturing operations. You will own process equipment knowledge, collaborate on technology transfers, and drive continuous improvement from development through scale-up and validation.

Role involves creating SOPs, liaising with suppliers, and ensuring compliance with FDA/EU quality systems while contributing to cost reductions and process optimization across manufacturing lines.