The Senior Technical Specialist will be a key 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 Senior 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.
The Senior Technical Specialist is responsible for 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 a high level of project management skill.
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 Senior Technical Specialist will model leadership behaviours and understand the lean/Six Sigma principles to drive a culture of continuous improvement building a High Performance Organisation.
- 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 complex troubleshooting/problem solving teams
- Serve as technical SME during regulatory inspections
- Provide technical stewardship, equipment resource planning and validation schedules
- 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
- Act as a deputy for the Technical Lead as required
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS:
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, technical support, etc.) working at SME level.
- At least 5 years' experience in the pharmaceutical industry or a similar operating environment with experience in a technical role in a pharmaceutical manufacturing environment.
- Experienced in application of Lean Six Sigma and Lean methodologies with a continuous improvement focus.
- Expert level understanding of regulatory and validation requirements.
- SME in product technical / scientific support
- Demonstrated experience in developing technical strategies and leading deployment and realization (e.e New product introduction, PPQ).
- MSc in Science, Technical or Engineering discipline
- Desirable evidence of Continuous Professional Development.
- Six Sigma Green Belt or equivalent
- Desirable project management qualification such as PMP etc.
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