Evotec
Principal Engineer - Global MSAT, Site based, Redmond, WA
Redmond · Principal
Sponsorship not specified$155k-$172kDetected 12 days ago
SparkStatisticsGMPCell CultureLeadershipTime ManagementMentoringOrganizational Skills
About the role
- 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.
- 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.
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.
- Develop Process transfer document and or Process Control strategy for phase III and commercial programs for receiving sites across the MFG network.
- Experienced in leading technology transfer and process validation activities for late-stage clinical manufacturing and commercial qualification PPQ campaigns/ commercial campaign support.
- Experience developing and providing oversight to continuous process monitoring strategies and process validation status throughout commercial lifecycle.
- Inclusive Culture: We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
- We can't wait to see where your curiosity leads you-and how it will shape the future of Just Evotec Biologics.
Requirements
- Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
- 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
- Strategic mindset, ability to organize, analyze/interpret, and effectively translate upstream expertise into global procedures/templates
Nice to have
- 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
- High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability.
- Whether it's professional courses, mentorship, or new projects, we'll help you grow.
- Additional Preferred Qualifications:
Compensation
- The base pay range for this position at commencement of employment is expected to be $155,000 to $172,000; Base salary offered may vary depending on the individual's skills, experience and competitive market value.
- Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
Benefits
- Growth Opportunities: We're a company that believes in continuous learning and development.
- Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
Company info
- 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!
- this is who we are
- The Role: / your challenge, …in our journey
- In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
- 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 i mplementation 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 f acility 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.
- Lead the analysis of process data including annual periodic reviews across the network of Manufacturing sites.
- Who You Are:
- 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)
- Considered a 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)
- Understanding of GMP concepts and quality systems necessary to execute process transfer and process validation activities.
Equal opportunity
- Evotec (US) Inc. is an Equal Opportunity Employer.
- Equal Opportunity Employer.
This listing is sourced directly from Evotec's careers page and normalized into a canonical job model.