Process Engineer II Global MSAT Downstream

Job Title: Process Engineer II - Global MSAT Downstream

Location: Redmond WA

Reports to: Director Technical Operations

About Us:

At Just-Evotec 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 whats possible. Were on a mission to create a place where curiosity isnt just encouraged its celebrated.

Are you someone who asks questions seeks answers and isnt afraid to go deeper#BeCureious with us and see where your curiosity can take you!

The Role:

Were looking for a passionate and curious Process Engineer II to join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.

As a Process Engineer II at Just-Evotec youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.

What Youll Do:

• 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.

Who You Are:

• Process Engineer II: Bachelors degree in engineering sciences or related program with 2-5 years of relevant experience or 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 process control

Why Join Us:

• Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.

• Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.

• Innovative Projects: Youll 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 dont just talk about thinking outside the box we throw the box away. If youve got ideas we want to hear them.

Are You Still Curious

If youve read this far then chances are youve got a curious mind just like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads you and how it will shape the future of Just-Evotec.

Let your curiosity guide your career #BeCurious and explore the endless possibilities at Evotec!

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 $83000 to $86250; Base salary offered may vary depending on the individuals 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.