Telephone: 087 2197421
Our client, a medical device company in Cork is currently looking to recruit a Technical Specialist for their site.
Job Description & Specific Objectives
- The Technical Specialist will be a team member in the Technical Operations Team which provides technical expertise to a growing site with an expanding portfolio of technologies and products. The successful candidate will work in a dynamic environment with exciting career opportunities.
- The Technical Specialist will provide technical support and expertise to the drug substance and drug product production areas to ensure the manufacture of quality pharmaceutical products in accordance with the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan.
- The Technical Specialist is responsible for supporting and/or leading a range of technical projects including process technology transfers, continuous improvement projects and capital upgrade projects. This role will need to proactively manage and resolve issues before they impact the business priorities and will require project management skills.
- The Tech Ops Department is a cross functional team providing technical support, guidance and direction to drug substance manufacturing, drug product manufacturing, laboratory operations and supply chain departments to ensure the success of the site. The Technical Specialist will model the leadership behaviours and understand the lean/Six Sigma principles to drive a culture of continuous improvement building a High Performance Organisation.
- The Technical Specialist will participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.
- Provide technical expertise and project leadership within a wide range of technical projects within the site, such as the validation of new equipment, improvement to the manufacturing processes, process tech transfer/new product introduction, process validation, etc.
- Provide technical review of change controls to ensure proposed changes are appropriately assessed from technical and validation perspectives
- Lead troubleshooting/problem solving teams
- Serve as technical SME during regulatory inspections
- Provide technical input into validation study design and execution
- 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.).
- Ensure highest Quality & EHS Compliance standards by serving as site SME for selected chapters for Quality and/or EHS standards
Qualifications & Experience - Knowledge and Skills Requirements
- Demonstrated technical knowledge of drug substance and/or drug product manufacturing.
- At least 3 years’ experience in the pharmaceutical industry or a similar operating environment with experience in a technical role in a pharmaceutical manufacturing environment.
- Demonstrated continuous improvement focus.
- Demonstrated problem solving and facilitation skills.
- Demonstrated project management and organisation.
- Experienced in application of Lean Six Sigma and Lean methodologies with a continuous improvement focus.
- Understanding of regulatory and validation requirements.
- SME in product technical / scientific support
- Demonstrated experience in developing technical strategies and leading deployment and realization (e.g – New product introduction, PPQ).
For further information on this Technical Specialist role in Cork please contact Anne - Marie Fox on 087 2197421 / email@example.com
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