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Chief Engineer Biotechnology Development - Redmond - Evotec

Job title: Principal Process Engineer, Upstream Technology
Description
OverviewCyprotex is a leading biotechnology company seeking a highly skilled and experienced professional to lead our bioprocess technology development efforts. As Principal Process Engineer, Upstream Technology, you will be responsible for designing and developing new equipment and technologies to improve our upstream manufacturing network.
About the Role
The selected candidate will join our GMSAT Technology team and lead cross-functional evaluations of technologies to improve and optimize upstream cell culture manufacturing. This role will involve developing support documentation for implantation of the technology into our global processing platform, providing technical and operational support to our Site MSAT and Manufacturing Operations groups, and participating in regulatory submissions and site inspections.
Key Responsibilities
- Develop strategies for the design and development of new and existing technologies across our biomanufacturing network
- Support the evaluation and approval of innovative technologies within the manufacturing platform through project governance
- Collaborate with key stakeholders and vendors to evaluate innovative technologies for implantation into the manufacturing process to increase efficiency and facility throughput
- Work with cross-functional teams on the development of global design documents based on platform process requirements and validation commissioning and qualification protocols
- Collaborate with the automation team on design and development of the Distributed Control System (DCS) with the manufacturing suite and integration of PLC-based systems into the DCS
- Evaluate single-use technologies for data acquisition and suitability within single-use manifolds and assemblies
- Work with vendors to test and develop equipment/technologies and develop required data and validation packages to support these technologies in a GMP environment
- Develop business processes, guidelines, SOPs, and training for processing equipment and technologies
Requirements
- BS in engineering, sciences, or related life science engineering
- 12+ years of relevant experience in Pharmaceutical, Biotech, or Life Sciences industries, or MS with 10+ years of experience
- SME knowledge in cell culture biopharmaceutical manufacturing, specifically around cell expansion, bioreactor design and operation, and perfusion system design and operation
- Understanding of downstream capture and clarification of cell culture harvest stream to drug substance
- Experience working with single-use instrumentation and assemblies within a GMP manufacturing facility
- Experienced in leading technology implementation and validation activities for clinical and commercial manufacturing readiness
- Understanding of GMP concepts and quality systems necessary to execute facility fit and process validation activities
- Demonstrated ability to work independently and collaboratively on cross-functional teams
Benefits
- Competitive salary range $111,360 - $159,000 per year
- Comprehensive benefits package including medical, dental, and vision insurance
- Short-term and long-term disability coverage
- Company-paid basic life insurance
- 401(k) company match
- Flexible work arrangements and generous paid time off policy
- Paid holidays and wellness programs
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