We are currently seeking a Senior Chemical Engineer with experience in High Potent Compound processing in either API or OSD.
This position will be a key member of the Process Development and Commercialisation group. The successful candidate will have the opportunity to work on a cross-functional team to design, install and start-up new potent facilities in either API or OSD (or both).
The successful candidate will also support internal and external manufacturing ensuring operations remain operational, continuously improve and innovate.
With their extensive range of facilities and environments, Engineers on site have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
- Wide depth and breadth in all aspects High Potent Compound processing either in API or OSD, or both.
- Acts as Subject Matter Expert in order to efficiently solve problems using appropriate tools and prior knowledge
- Process transfer/New product introduction activities related to high potent compounds including completing process safety evaluations (including PHA), process fits, technology transfer etc.
- Influences interactions with key partner groups, and helps to set strategy and tactics across functions
- Acts as the department primary technical rep on a cross-functional team for all stages of the the capital project
- Reviews and contributes to project design documents covering equipment, facilities, utilities etc.
- In conjunction with the operating area develops operating procedures, SOPs and start up documentation
- Leads the site aspects of the facility qualification and start up, including documentation generation, execution, resolution of issues and close out.
- Mentors and coaches staff within the organization in high potent handling on an an-going basis.
- Lead developing a high potent processing "capability build" sustain plan for the site to include people development, business systems improvements and infrastructure/technology investments.
- BSc Chemical Engineering (or equivalent) preferred.
- Minimum of 5+ years' experience in the pharmaceutical industry with specific experience in High Potent Compound (OEB4/5) processing in API or OSD, or both.
- Knowledge of process development, commercialisation and supply systems as well a solid knowledge of global GMP and regulatory requirements is an advantage
- Engineering Principles, Process Chemistry and Formulation Technology
- Knowledge of containment technologies and High Potent (OEB4/5) processing.
- Process development & scale up methodologies, including understanding of analytical techniques, Lean principles and PAT
- Productive communication and interpersonal skills with ability to communicate technical information both verbally and written in a concise manner.
- Ability to scientifically evaluate projects, suggest appropriate options, solutions and timelines.
- Strategic thinking
- Project management
- Build talent - Champion and support innovation and continuous learning
- Team work skills and ability to work across boundaries
- Demonstrates and promotes the principles of inclusion
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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