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

Role Summary

The Process Engineer III, Downstream–Site MSAT will join a fast-paced, collaborative, and multidisciplinary team to support downstream processing for multiple clinical-scale cGMP manufacturing trains on a 24/7 continuous processing platform. The role reports to the Downstream Lead for site MSAT and represents technical SME input on internal and external projects, interfacing with global MSAT, Manufacturing Operations, and Quality functions. This position focuses on driving process improvements, validating processes, and supporting audits and investigations in a site-based setting covering Redmond, WA and Seattle, WA.

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
• Partners with Quality, Validation and Global MSAT to develop and implement process validation and comparability studies leading to successful product registration
• Acts as SME for regulatory and client inspection audits
• Utilizes technical skills to participate and/or lead investigations related to process issues/deviation; drives 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; conducts root cause analysis (RCA) as needed
• Supports and participates in on-call rotation to support 24/7 operations
• Applies Operational Excellence principles to lead continuous improvement ideas for downstream manufacturing

Qualifications

• 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 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, as they relate to drug substance biological manufacturing
• Good interpersonal, team, and collaborative skills

Education

• Masters (or Bachelors) degree in Engineering

Additional Qualifications

• Experience in supporting audits and inspections by health authorities, clients and other external auditors
• Experience in risk assessment and risk management for pharmaceutical products and processes; familiarity with Quality by Design
• Entrepreneurial drive to achieve business objectives