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.
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.
- 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.
- 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).
- Skilled communicator with demonstrated successes in a team environment, such as project teams, Six Sigma team, continuous improvement, capital projects, etc.
- Demonstrated ability to realize improvement initiatives, through leadership of teams.
- Demonstrated ability in holding project team members responsible for results and being decisive about non-performers
- Skilled at stakeholder management and change management such as change execution methodology
- 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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