Process Engineer II - Downstream - Site based, Redmond, WA

About the position

Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer II for site MSAT to join a fast-paced, collaborative, and multidisciplinary team. The role report to Downstream Lead for site MSAT, and will be responsible to support all aspects of downstream processing for multiple clinical-scale cGMP manufacturing trains employing the innovative Just-Evotec continuous processing platform in 24/7 operations.

Responsibilities

• Represents site MSAT on project teams as technical subject matter expert (SME) and interface with global MSAT, Operations and Quality functions.
• Develop process understanding and expertise.
• Authors, reviews and owns process related documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc).
• Authors, reviews change controls including managing change implementation of the change as the assigned change agent.
• Utilize technical skills and process knowledge to participate and/or lead investigations related to process/ New product implementation.
• Collaborate with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check.
• Monitors and reports on process performance data analysis.
• Ability to share 24/7 on call support activities during production.
• Apply Operational Excellence principles to lead continuous improvement for downstream process improvements.

Requirements

• Masters (or Bachelors) degree in Engineering with 2+ (5+) years of pharmaceutical/biotech experience including a minimum of 2-4 years of supporting downstream purification activities for biopharmaceutical products.
• 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.
• Good interpersonal, team, and collaborative skills are required.
• Excellent verbal and written communication skills in English; ability to interface with all levels of the organization.
• Experience in leading risk assessment and risk management for pharmaceutical products and processes.
• Experience in applying principles of Quality by Design.

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 and paid holiday
• Wellness and transportation benefits