Principal Engineer - Global MSAT, Site based, Redmond, WA

Cyprotex•Redmond, WA

16h•Onsite

About The Position

Just Evotec Biologics is seeking a highly motivated Principal Process Engineer to join their Global MSAT team. This role offers a significant opportunity to improve worldwide access to biotherapeutics. The primary focus is to provide project leadership for late-stage molecule process transfer/tech transfer for clinical and commercial biologics manufacturing. This includes supporting the development and maintenance of technical documentation for process control and validation strategies. As part of the Global MSAT Tech Transfer team, the candidate will support the implementation of network alignment strategy and creation of global templates/documentation for Tech Transfer/New Product Introduction across the JUST Evotec Manufacturing network. The team member will also provide onsite support for new facility or client startup engineering runs and performance qualification runs, assist in the generation of relevant regulatory submissions, and provide support for regulatory and site inspections. This role may also include direct reports/management of junior process engineers.

Requirements

Bachelor’s degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
Subject matter expert in cell culture biopharmaceutical manufacturing and or development of cell culture processes including perfusion technologies, single use bioreactor operations, and scale-up strategies (Upstream).
Subject matter expert in downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, but also knowledgeable in single-use bioreactors and perfusion technology. (Downstream)
Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
Solid background in statistical analysis.
Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments.
Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems.
Strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
Strategic mindset, ability to organize, analyze/interpret, and effectively translate upstream expertise into global procedures/templates.
Demonstrated skill managing and mentoring direct reports.

Nice To Haves

Recognized technical mastery of either upstream or downstream operations and continuous processing bench-scale through commercial manufacturing scale.
Knowledge and expertise to solve complex technical problems; may apply novel approaches that provides significant technology advancement.
Experience leading technical projects with external collaborators and vendors.
Ability to navigate global regulatory CMC documents.
High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.

Responsibilities

Project Lead for technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
Lead site to site Tech Transfer activities.
Lead technology transfer activities ensuring gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
Support development, review and approval of technical documentation including global protocols for performance qualifications, batch records, and reports related to engineering, GMP and PPQ runs.
Lead the development and implementation templates for Process Validations and Continued Process Verification strategies.
Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.