Process Engineer II – Downstream

Jobtailor; Redmond (WA); On-site; USD 120,000 - 160,000; Full time

Job summary

Jobtailor in Redmond, WA is seeking an experienced MSAT professional to act as a technical SME on project teams and lead purification processes for biopharmaceutical products. The role involves developing process understanding, authoring critical documentation, and driving CAPA closure within GMP environments.

The candidate should have a engineering degree, 2–5 years in pharma/biotech, and strong collaboration, communication, and change-management skills.

Qualifications

• Master's or Bachelor's degree in Engineering.
• 2+ (5+) years of pharmaceutical/biotech experience.
• 2-4 years supporting downstream purification activities for biopharmaceutical products.
• Proven leadership in GMP pharmaceutical/biotechnology.
• Experience with disposable-based manufacturing technologies.
• Ability to drive change and influence stakeholders.
• Excellent verbal and written communication in English.
• Experience in risk assessment and risk management for products/processes.
• Knowledge of Quality by Design principles.

Responsibilities

• Serve as technical SME on project teams and develop process understanding.
• Author, review and own process documentation, test protocols, batch records and SOPs.
• Review change controls and manage implementation.
• Lead investigations related to process or new product implementation.
• Collaborate to drive CAPAs from approval to closure and effectiveness check.
• Monitor and report on process performance data.
• Provide 24/7 on-call support during production.
• Apply Operational Excellence to drive downstream process improvements.

Skills

GMP knowledge

Leadership

English communication

Collaborative teamwork

Problem solving

Education

Bachelor's or Master's in Engineering

Job description

Responsibilities

• Represents site MSAT on project teams as technical subject matter expert (SME)
• Develops 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
• Utilizes technical skills and process knowledge to participate and/or lead investigations related to process/New product implementation
• Collaborates with impacted groups to drive implementation of CAPAs from approval to closure & effectiveness check
• Monitors and reports on process performance data analysis
• Shares 24/7 on call support activities during production
• Applies Operational Excellence principles to lead continuous improvement for downstream process improvements

Requirements

• Masters (or Bachelors) degree in Engineering
• 2+ (5+) years of pharmaceutical/biotech experience
• 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
• Technical purification and solution preparation operations using disposable-based manufacturing technologies
• Demonstrated capabilities to work with high-performing teams
• Ability to drive change and influence internal and external stakeholders
• Good interpersonal, team, and collaborative skills
• Excellent verbal and written communication skills in English
• Experience in leading risk assessment and risk management for pharmaceutical products and processes
• Experience in applying principles of Quality by Design.