Job Title: Manufacturing Process Specialist
We are seeking a highly skilled Manufacturing Process Specialist to join our team at Horizon. This is an excellent opportunity to work with a world-class manufacturing operation, delivering high-quality medicines to patients around the world.
About the Role:
* Provide technical leadership and support for manufacturing operations.
* Develop SOPs for new manufacturing processes.
* Collaborate with vendors for equipment procurement.
* Establish critical processes.
Key Responsibilities:
Technical Leadership:
* Serve as Subject Matter Expert (SME) in formulation, aseptic filling processes, and isolator technology.
* Represent the team at regulatory audits.
Equipment Ownership:
* Own manufacturing equipment, process knowledge, and technology.
Process Improvement:
* 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.
Regulatory Compliance:
* Establish specifications for process parameters, process controls, and equipment effectiveness.
* Implement statistical process control systems.
* Monitor and analyze process data during drug product manufacturing.
Communication:
* Liaise with operations, quality, and S&T to optimize equipment and process performance.
Requirements:
* Minimum level 8 qualification in an engineering, science, or technical discipline.
* At least three (3) years in pharmaceutical process engineering.
* Strong record of achievement.
* Demonstrated experience of technical writing of complex issues.
* Must have experience in taking a lead role in investigations.
Benefits:
* Paid Holidays
* Pension Fund
* Medical Aid / Health Care