What are the responsibilities and job description for the Principal Process Engineer, Upstream Technology (Redmond, WA main site based) position at Cyprotex?
Just-Evotec Biologics is seeking a motivated and creative Process Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.
The selected candidate in the role of Principal Process Engineer as part of the GMSAT Technology team will lead the team responsible for the design and development of new equipment and technologies for the Just-Evotec upstream manufacturing network. The role will lead cross functional evaluations of technologies to improve and optimize upstream cell culture manufacturing, develop the support documentation for implantation of the technology into our global processing platform and provide technical and operational support to Just-Evotec’s Site MSAT and Manufacturing Operations groups. The role may also provide person-in-plant support, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.
Note : This role will be site based in Redmond, with travel to Seattle, WA. Toulouse site would be 2 to 3 weeks per quarter, once settled for the first year or as and when required.
Responsibilities (including but are not limited to) :
- Develop strategies for the design and development of new and existing technologies across the Just-Evotec Biological Manufacturing network.
- Support the evaluation and approval of innovative technologies within the manufacturing platform through the project governance group.
- Work 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 (user requirement specifications, software functional specifications) based on platform process requirements and validation commissioning and qualification protocols.
- Collaborate with the automation team on design and development of the Distribute Control System (DCS) with the manufacturing suite and integration of PLC based systems into the DCS.
- Support technical evaluations of the facility utility requirements, layouts within the manufacturing area and support associated CQV (Commissioning, Qualification, and Validation) activities.
- 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 the required data and validation packages to support these technologies in a GMP environment.
- Develop business processes, guidelines, SOPs (Standard Operating Procedures), and training for processing equipment and technologies.
- Build the equipment maintenance & life cycle plans to support the equipment deployed in the manufacturing network.
- Partner with Site MSAT Manufacturing Technology & Science teams on global and site objectives.
- Provide subject matter expert support in Non-Conformance investigation, CAPAs and provide process impact evaluations of equipment issues.
- Participate in internal and external audits / inspections.
Position Requirements :
Additional Preferred Qualifications :
This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.
The base pay range for this position at commencement of employment is expected to be $111,360 to $159,000; Base salary offered may vary depending on the individual’s skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.
Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
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Salary : $111,360 - $159,000
