Manufacturing Process Specialist
We are seeking a Manufacturing Process Specialist for our pharmaceutical client in Sligo. As a key member of the team, you will provide technical leadership and support for manufacturing operations.
Key Responsibilities
* 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 and 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.
* Supervise external contractors.
Requirements
* 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 and previous experience in lyophilization and sterilization operations preferable.