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.
Requirements
Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
Considered a 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)
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 p
Benefits
Health insurance
Additional Information
Job Title: Principal Process Engineer
About Us: this is who we are
At Just Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated.
Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!
The Role: / your challenge, ...in our journey
We're looking for a passionate and curious Principal Process Engineer to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
As a Principal Process Engineer at Just Evotec Biologics , you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team.
Just is seeking a highly motivated Principal Process Engineer in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide project leadership for late-stage molecule process transfer / tech transfer for clinical and commercial biologics manufacturing, including the support for development and maintenance of technical documentation for process control and validation strategies.
The selected candidate as part of the Global MSAT Tech Transfer team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across 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 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.
Evotecgroup · Redmond