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

Role Summary

Process Engineer III, Downstream–Site MSAT at Just Evotec Biologic (Redmond, WA and Seattle, WA) supporting site MSAT downstream processing for multiple clinical-scale cGMP manufacturing trains in 24/7 operations.

Responsibilities

• Promotes a culture of safety
• Represents site MSAT on internal and external project teams as SME; interfaces with global MSAT, Manufacturing Operations, and Quality functions
• Possesses deep understanding of downstream processes for purification of biologics
• Authors, reviews, and approves process-related documentation (technical documents, test protocols, batch records, process descriptions, SOPs)
• Leads complicated multi-disciplinary change controls and acts as project lead
• Partners with Quality, Validation, and Global MSAT to develop/implement process validation and comparability studies
• Acts as SME for regulatory and client inspection audits
• Participates in investigations related to process issues/deviations; drives CAPA implementation to closure and effectiveness
• Facilitates new product introduction by leading make-a-batch sessions and supporting technical training
• Organizes data to optimize analysis and trending; uses RCA tools
• Support and on-call rotation to support 24/7 operations
• Applies Operational Excellence to lead continuous improvement in downstream manufacturing

Qualifications

• Masters (or Bachelors) degree in Engineering with 4+ (7+) years of pharmaceutical/biotech experience; minimum 2+ years in downstream purification for biopharmaceuticals
• Knowledge/experience with CMC stage gates for clinical and commercial biologics drug substance manufacturing
• Proven record of self-directed leadership in GMP pharmaceutical/biotechnology
• Technical purification and solution preparation operations using disposable-based manufacturing technologies
• Ability to work with high-performing teams, drive change, influence stakeholders
• Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines related to biologics manufacturing
• Strong interpersonal, team, and collaborative skills

Skills

• Downstream purification expertise; process documentation; change control; validation and comparability studies; audits and inspections; RCA; CAPA; data analysis; 24/7 operations support

Education

• Masters (or Bachelors) in Engineering

Additional Requirements

• Experience in audits/inspections as presenter or support staff
• Experience with risk assessment, Quality by Design
• Entrepreneurial drive to achieve business objectives