Manufacturing Process Specialist
Team Horizon is seeking a Manufacturing Process Specialist for a client in Sligo to support Pharmaceutical Operations. The role involves providing technical leadership and direction for the manufacturing department across various areas including formulation, aseptic filling process, isolator technology, and representation at regulatory audits.
Why you should apply:
- Opportunity to join a world-class manufacturing operation with a proven track record of delivering high-quality medicines globally.
- Strong culture of continuous improvement and innovation aimed at improving health outcomes and lives.
- Capability development to produce all medicines in-house, ensuring supply continuity as the company expands internationally.
What you will be doing:
- Owning manufacturing equipment, process knowledge, and technology on-site.
- Sourcing and procuring process equipment with technical oversight.
- Providing technical support for manufacturing processes and equipment, collaborating with technical teams to ensure standardization and best practices.
- Designing and implementing technical studies and programs for investigations and product improvements.
- Developing knowledge of new pharmaceutical manufacturing processes aligned with business goals.
- Managing continuous improvement projects and collaborating with leadership to implement initiatives.
- Driving process improvements for performance enhancement and cost reduction.
- Establishing process specifications, controls, and equipment effectiveness standards.
- Implementing statistical process control systems in collaboration with manufacturing and quality teams.
- Monitoring and analyzing process data during manufacturing.
- Overseeing planning, execution, and reporting of technology transfer projects.
- Supporting new product and process introductions at the site.
- Leading root cause analysis and corrective actions for process deviations.
- Conducting risk assessments to ensure health and safety.
- Developing and updating procedures to support manufacturing operations.
- Participating in validation efforts for processes, equipment, and facilities.
- Collaborating with operations, quality, and S&T to optimize equipment and process performance.
- Adhering to policies related to quality and safety.
- Ensuring successful external and internal audits.
- Supervising external contractors.
What you need to apply:
- A relevant third-level qualification in science, engineering, or a technical discipline; a Master's or PhD in engineering, chemical, or process engineering is advantageous.
- At least 3 years' experience in pharmaceutical process engineering, including batch processing, technical transfers, scale-up, commissioning, and validation in a cGMP environment.
- Proven project management skills, capable of delivering projects on time, within budget, and to quality standards.
- Experience in lyophilization and sterilization operations is preferred.
#J-18808-Ljbffr