Principal Process Validation Engineer (Redmond, WA)

About the position

Just is seeking a highly motivated Principal Process Validation Engineer in Global MSAT team that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to provide project leadership of process validation activities for late-stage programs into PPQ/ commercial biologics manufacturing. The selected candidate as part of the Global MSAT Tech Transfer and Process Validation team is responsible for supporting the implementation of network alignment strategy and creation of global templates/documentation for Process Validation across JUST Evotec Manufacturing network. The team member will also provide support for new facility startup engineering runs and performance qualification runs, assist in generation of relevant regulatory submissions, and provide support for regulatory and site inspections. This role may also include direct reports/management of junior process engineers.

Responsibilities

• Project Lead for Process Validation activities of late-stage molecule/ commercial manufacturing and/or PPQ campaign support.
• In collaboration with cross functional teams, develop Process Validation Master Plans, provide process knowledge to support Process Characterization, and perform Process Validation risk assessments.
• Development, review and approval of technical documentation including global protocols for Process Performance Qualification runs, Process Validation studies, and associated reports related to engineering, GMP and PPQ runs.
• Lead the development and implementation of templates for Process Validation and Continued Process Verification strategies.
• Support the generation of governance policies and related SOPs for Process Validation.
• Manage project-specific deliverables including but not limited to PVMP, PPQ protocols and supporting validation such as mixing, hold time studies, impurity clearance, extractables & leachables, filter validation etc.
• Support technology transfer activities ensuring process gap analysis/risks assessments are performed and mitigation plans are in place and ensuring design spaces (PAR & NOR ranges) are built for critical process parameters for validation and support of late stage/commercial manufacturing operations.
• Support the analysis of process data including annual periodic reviews across the network of Manufacturing sites.

Requirements

• Bachelor's degree in engineering science or related program with 12+ years relevant experience or 8+ years of relevant experience with an MS.
• Proven experience in leading Process Validation activities for late-stage clinical manufacturing, PPQ campaigns/ commercial campaign support.
• Understanding of GMP concepts and Quality systems necessary to execute process validation activities.
• Experience developing and providing oversight to Continuous Process Monitoring strategies and Process Validation status throughout commercial lifecycle.
• Apply manufacturing process lifecycle management principles for establishment and continuous improvement of process control strategy.
• Experience authoring regulatory CMC documents, coordinating responses to health authority questions, and providing inspection support.
• Solid background in statistical analysis.
• Strategic mindset, ability to organize, analyze/interpret, and effectively translate process validation expertise into global procedures/templates.
• Good interpersonal, team, and collaborative skills.
• Excellent oral and written communication skills.
• Demonstrated skills managing or mentoring junior engineers or direct reports.
• Proven knowledge of cGMP requirements and experience writing manufacturing technical documents.
• Experience leading technical projects and managing timelines with external collaborators and vendors.
• Candidate must possess a strong focus on quality and attention to detail as well as effective task/ time management organizational skills.

Nice-to-haves

• Subject matter expert in the area of either upstream or downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, single-use bioreactors and perfusion technology.
• Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems.
• Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement.
• Ability to navigate global regulatory CMC documents.

Benefits

• Medical, Dental and Vision insurance
• Short-term and long-term disability
• Company paid basic life insurance
• 401k company match
• Flexible work
• Generous paid time off and paid holiday
• Wellness benefits
• Transportation benefits