Evotec · 1 day ago
Process Engineer III - Site Based, covering Redmond & Seattle, WA
Redmond, WA
Full-time
Hybrid
Mid, Senior Level
$92K/yr - $126K/yr
7+ years expJust Evotec Biologic is a forward-thinking team dedicated to innovation and success. They are seeking a passionate and curious Process Engineer III to support downstream processing for clinical-scale cGMP manufacturing trains, driving impactful projects and collaborating with multidisciplinary teams.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Promotes a culture of safety
Represents site MSAT on internal and external project teams as technical subject matter expert (SME) and interfaces with global MSAT, Manufacturing Operations and Quality functions
Possesses a deep understanding of downstream processes for the purification of biologics
Authors, reviews and approves process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
Leads complicated and multi-disciplinary change controls and will function as a lead for the project team
Partner with Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration
Is confident to act as a subject matter expert for regulatory and client inspection audits
Utilize technical skills and process knowledge to participate and/or lead investigations related to process issues/deviation. Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing
Skilled at organizing data to optimize analysis and trending
Experienced investigator and knowledgeable of root cause analysis tools (RCA)
Support and on-call rotating to support 24/7 operations
Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing
Qualification
Required
Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience including a minimum of 2+ years of supporting downstream purification activities for biopharmaceutical products
Knowledge and experience CMC stage gates for clinical and commercial biologics drug substance manufacturing programs
Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required
Technical purification and solution preparation operations using disposable-based manufacturing technologies
Demonstrated capabilities to work with high-performing teams, drive change, and influence internal and external stakeholders
Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing
Good interpersonal, team, and collaborative skills are required
Preferred
Experience in supporting audits and inspections by health authorities, clients and other external auditors as a presenter or audit support staff
Experience in leading risk assessment and risk management for pharmaceutical products and processes
Experience in applying principles of Quality by Design
Entrepreneurial drive to achieve business objectives
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