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 implementation 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 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.
What You’ll Do:
- Support 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.
Who You Are:
- 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 upstream processing including single-use bioreactor operations and perfusion technology either at Manufacturing scale or in process development of biologics
- 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 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 upstream or downstream and disposable manufacturing technologies either at Manufacturing scale or at bench-scale.
- Applies knowledge to solve complex technical problems.
- Technical resource for Upstream or 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 process control
Why Join Us:
- Growth Opportunities: We’re a company that believes in continuous learning and development. Whether it’s professional courses, mentorship, or new projects, we’ll help you grow.
- Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life. Site based role.
- Inclusive Culture: We’re committed to building a diverse and inclusive environment where everyone’s voice is valued, and curiosity is encouraged.
- Innovative Projects: You’ll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- A Place for Big Ideas: We don’t just talk about thinking outside the box—we throw the box away. If you’ve got ideas, we want to hear them.
Are You Still Curious?
If you’ve read this far, then chances are you’ve got a curious mind—just like us. So, what are you waiting for? Take the leap and apply today. We can’t wait to see where your curiosity leads you—and how it will shape the future of Just Evotec Biologics.
Let your curiosity guide your career—#BeCurious and explore the endless possibilities at Just Evotec Biologics!
The base pay range for this position at commencement of employment is expected to be $92,400 to $126,500; this is a salary exempt role. 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, 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.
Skills Required
- Bachelor's degree in engineering, sciences, or a related program with 5 or more years of relevant experience, or a master's degree with 2 or more years of relevant experience
- Experience supporting process transfer or technology transfer projects in the biopharmaceutical industry
- Experience with process risk assessment tools such as FMEA, process models, and process trending
- Understanding of upstream processing, including single-use bioreactors and perfusion technology
- Understanding of downstream processing, including process chromatography, continuous chromatography, large-scale column packing, viral filtration, and tangential flow filtration
- Understanding of GMP concepts and quality systems supporting technology transfer and process validation
- Hands-on experience with disposable-based manufacturing technologies from bench scale through commercial scale
- Working knowledge of manufacturing process equipment and automation systems
- Strong quality focus, attention to detail, task management, time management, and organizational skills
- Ability to organize, analyze, interpret, and communicate process data effectively
- Strong interpersonal, teamwork, collaboration, oral communication, and written communication skills
- Commercial manufacturing campaign support experience
- Additional upstream or downstream and disposable manufacturing technology experience
- Ability to serve as a technical resource for upstream or downstream manufacturing processes and platforms
- Ability to work independently and in project teams and potentially lead functional projects
- Ability to navigate global regulatory CMC documents
- Experience supporting late-stage manufacturing, technology transfer, or process validation studies
- Experience with DeltaV for process control
What We Do
Evotec is a biotechnology company that is committed to advancing drug discovery and development. Through flexible business models, we collaborate with pharmaceutical companies, biotechs, foundations, and government agencies on a substantial scale. We believe that by working together, we can make a difference in the lives of patients. Our Pipeline Co-Creation model represents our adaptable, multi-modality, fully integrated end-to-end approach to drive collaborations and services across all phases of drug discovery and development – from discovery of novel targets to achieving Proof of Concept in the clinic and into commercial manufacturing. We aspire to contribute data-driven disease understanding and early disease relevance in humans to bring the probability of success up. We select the right modality, which is then propelled forward on our platforms by our passionate people striving for the fastest and most effective ways towards patient impact. This is enabled by convergence of human ingenuity with data and AI. We also offer specific solutions, products, and CRO/CDMO-like services, always in support of the Biopharma R&D innovator. Our more than 4,000 scientists work closely with numerous partners concurrently, delivering fully integrated research and development portfolios or individual projects with the highest quality standards and efficiency, coupled with great science, passion, engagement, and communication.
