Description
Role - Sterile Technical SpecialistLocation - Co. Cork, Ireland
Type - initially 12 months
The Role
The Technical Specialist will provide technical process support and expertise to the manufacture and introduction of quality pharmaceutical products in accordance to meeting the organisation priorities of: Compliance, Supply, Strategy and Profit Plan.
Key Responsibilities:
- The Technical Specialist is accountable for supporting all technical components of the process to deliver an effective and efficient value stream and the flawless introduction of new products.
- The Technical Specialist is responsible for actively participating in the Tier process to manage technical projects and proactively resolve issues before they impact the business priorities.
- The Technical Specialist will be an active member within the cross functional team providing support, guidance and strive for Technical excellence to ensure success
- The Technical Specialist will participate and comply with all Quality Management System (QMS) requirements, including ownership, as relevant to you.
- Provide ongoing coaching and support to the cross functional team members, to share their technical knowledge and promote best practices.
- Ensure supply of high quality product through ensuring equipment availability, maximise performance through OEE and continuous process improvement initiatives.
- Provide Technical stewardship, equipment resource planning and validation schedules.
- Ensure highest Quality & Compliance standards.
- Provide Technical expertise within a wide range of technical projects, such as the validation of new equipment, improvement to the filling process etc.
- Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools such as: problem solving, standardisation, reducing cycle time, Lean principles within the process.
- Degree or 3rd level qualification (Production, Mechanical, Process, Industrial, Electrical)
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (eg manufacturing, quality, engineering, etc).
- Experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical role in a manufacturing environment.
- Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
- Demonstrated leadership skills with a continuous improvement focus.
- Project Management Experience leading projects.
- Process and technology background.
- Autoclave cycle development and validation experience.
- Equipment and process validation experience.
- Demonstrated high level of problem solving and facilitation skills.
- Advanced PC skills such as Excel, Word, PowerPoint.
- Stakeholder management of multi decision makers, colleagues, peers and cross functional teams
- Desirable for Six Sigma Green Belt
- Desirable project management qualification such as PMP etc.