Process Engineer III - Site Based, covering Redmond & Seattle, WA

Role Summary

Process Engineer III, Downstream–Site MSAT. Site-based role covering Redmond & Seattle, WA. Responsible for supporting all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the Just-Evotec continuous processing platform in 24/7 operations. Reports to Downstream Lead for site MSAT.

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
• 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 CAPA implementation from approval to closure & effectiveness check
• Facilitates new product introduction by leading make-a-batch sessions and supporting technical training for manufacturing
• Organizes data to optimize analysis and trending
• Investigates root causes using RCA tools
• Support and on-call rotating to support 24/7 operations
• Apply Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing

Qualifications

• 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 with 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
• Technical purification and solution preparation operations using disposable-based manufacturing technologies
• Ability 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 related to drug substance biological manufacturing
• Good interpersonal, team, and collaborative skills

Skills

• Downstream purification expertise
• Documentation, validation and change control management
• Regulatory and client inspection preparedness
• Investigation and RCA capabilities
• Data organization, analysis and trending
• Operational Excellence and continuous improvement

Education

• Engineering degree (Master's preferred) with relevant pharmaceutical/biotech experience

Additional Requirements

• Experience supporting audits/inspections by health authorities or clients (preferred)
• Experience with risk assessment, risk management, and Quality by Design (preferred)
• Entrepreneurial drive to achieve business objectives (preferred)