Manufacturing Process Specialist
Team Horizon is seeking a highly skilled Manufacturing Process Specialist to provide technical leadership and support for our pharmaceutical client in Sligo.
Key Responsibilities:
* Develop and implement manufacturing processes, SOPs, and technical studies to support investigations and product improvements.
* Source and procure process equipment with technical oversight and collaborate with vendors as needed.
* Represent the team at regulatory audits and ensure compliance with FDA and EU regulations.
* Design and implement statistical process control systems, monitor and analyze process data during drug product manufacturing.
* Oversee planning, execution, and reporting for technology transfer projects and supervise external contractors.
* Support the introduction of new products and processes, lead root cause analysis and corrective actions for process deviations.
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.
* Strong record of achievement and demonstrated experience of technical writing of complex issues.
* Must have experience in taking a lead role in investigations and high level of technology experience.
* Good knowledge of quality systems both FDA and EU regulations as they relate to manufacturing, facilities, and process engineering.
* Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements.