Support downstream technology transfer of a Late-Stage molecule/ commercial manufacturing and/or PPQ campaign support.
Support site to site Tech Transfer activities
Support 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.
Author templates for Process Validations and Continued Process Verification strategies.
Conduct the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
Author Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the Just MFG network.
Requirements
Bachelor's degree in engineering, sciences, or related program with 5 + years of relevant experience, 2 years of experience with an MS degree
Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
Familiar with process risk assessment tools (e.g., FMEA) developing process models, and process trending.
Solid understanding of downstream processing including process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration either at Manufacturing scale or in process development of biologics.
Solid understanding of GMP concepts and quality systems necessary to support Tech Transfer and process validation activities.
Hands on experience of downstream disposable-based manufacturing technologies from bench-scale through commercial scale
Working knowledge of manufacturing process equipment and automation systems
Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills.
Ability to organize, analyze/interpret, and effectively communicate process data.
Good interpersonal, team, and collaborative skills are a must.
Excellent oral and written communication skills
Additional Preferred Qualifications:
Practical experience or knowledge downstream and disposable manufacturing technologies either at Manufacturing scale or at bench-scale.
Applies knowledge to solve complex technical problems.
Technical resource for Downstream Manufacturing process and platform.
Can work independently and in project teams; May lead projects within functional area expertise at Just Evotec.
Ability to navigate global regulatory CMC documents.
Experience with supporting late-stage manufacturing, Tech transfer and or Process Validation studies
Experience with DeltaV for
Additional Information
Job Title: Process Engineer III
Shifts: Monday to Friday, Days
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 [Job Title] 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 Process Engineer III 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 Process Engineer downstream in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics.
The selected candidate as part of the Global MSAT Tech Transfer team supports Tech transfer leads with the i mplementation of network alignment strategy and creation of global templates/documentation for Tech transfer/New Product introduction across JUST Evotec. The primary focus of this job is to support site to site downstream tech transfer for late stage clinical and commercial biologics across the Manufacturing network. The staff member may also provide person-in-plant support, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections.
Evotecgroup · Redmond