The Technical Specialist will be a key team member in the Technical CoE, which provides technical expertise to a growing site with an expanding portfolio of technologies and products. The Technical Specialist will provide technical support and expertise to the production areas to ensure the manufacture of quality pharmaceutical products in accordance with the company’s Manufacturing Division priorities of Compliance, Supply, Strategy and Profit Plan. The Technical Specialist is responsible for actively participating in the Tier process to manage technical projects and proactively manage and resolve issues before they impact the business priorities. The Technical Specialist will be an active member within the cross functional CoE providing support and guidance and will strive for technical excellence to ensure the success of the CoE. The Technical Specialist will participate and comply with the company’s Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant. This role reports to the Technical CoE Team Lead.
• 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 by providing technical and scientific product and process support to maximise process performance (product lifecycle management, continuous process improvement initiatives, etc.)
• Provide technical stewardship, equipment resource planning and validation schedule.
• Ensure highest quality & compliance standards.
• Provide technical expertise and leadership within a wide range of technical projects within the CoE, such as the validation of new equipment, PPQ, new product introduction, product deletion, etc.
• Act as a deputy for the Technical CoE Team Lead as required.
• Degree in Science or Engineering discipline (preferably MSc.)
• At least five years’ experience in the pharmaceutical industry or a similar operating environment with experience in a technical role in a pharmaceutical manufacturing GMP environment.
• Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
• Experience in product technical / scientific support.
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, technical support, etc.)
• Demonstrated leadership skills with a continuous improvement focus.
• Experience managing and leading projects.
• Providing SME level support.
• Demonstrated ability to realize improvement initiatives through leadership of teams.
• Demonstrated high level of problem solving and facilitation skills.
• Stakeholder management of multiple decision makers, colleagues, peers and cross functional teams.
• Desirable evidence of Continuous Professional Development.
• Desirable Six Sigma Green Belt.
• Desirable Project Management qualification, e.g.PMP.
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