Manufacturing Process Specialist

AbbVie

Sligo, Ireland

As a Manufacturing Process Specialist you'll play a key role in providing technical leadership and support for manufacturing operations.

You will be at the forefront of room and equipment qualification, developing SOPs for new manufacturing processes, collaborating with vendors for equipment procurement, and establishing critical processes.

Responsibilities will include:

Serve as a Subject Matter Expert (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.

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.
Strong record of achievement.
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.