Evotec · 6 hours ago
Senior Process Engineer - Site Based, Redmond, WA
Redmond
Full-time
Onsite
Senior Level, Lead/Staff
$113K/yr - $154K/yr
8+ years expJust Evotec Biologics is a forward-thinking team that thrives on curiosity and innovation. They are seeking a passionate Senior Process Engineer to drive impactful projects and collaborate on complex problems in the field of biotherapeutics manufacturing. The role involves project leadership for late-stage molecule process transfer and supporting the development of technical documentation for process control and validation strategies.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
Support the development and implementation templates for Process Validations and Continued Process Verification strategies
Support 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 Just MFG network
Qualification
Required
Bachelor's degree in engineering, science or related program with 10+ 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
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 process equipment and automation systems (DeltaV)
Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
Strategic mindset, ability to organize, analyze/interpret, and effectively translate upstream expertise into global procedures/templates
Preferred
Recognized technical mastery of cell culture unit operations including perfusion technologies, continuous processing disposable manufacturing technologies from bench-scale through commercial scale
Knowledge and expertise to solve complex technical problems; may apply novel approaches that provide significant technology advancement
Experience leading technical projects with external collaborators and vendors
Ability to navigate global regulatory CMC documents
High level of demonstrated initiative, exhibit flexibility in work approach, and demonstrate strong follow through and accountability
Benefits
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
Paid holiday
Wellness and transportation benefits
Company
Evotec
Evotec is a pharmaceutical and life science company that provides drug discovery and gene therapy solutions.
5001-10000 employees
H1B Sponsorship
Evotec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (2)
2022 (2)
2021 (3)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$746.74MKey Investors
Bill & Melinda Gates FoundationKorea Advanced Institute of Science and TechnologyOpen Philanthropy
2025-05-07Grant· $2.5M
2025-01-22Grant
2023-12-19Grant· $2.5M
Leadership Team
Christian Wojczewski
CEO
Claudia Karnbach
EVP, Global Head of Partnerships and Alliances
Recent News
2026-01-07
Company data provided by crunchbase