MSAT Process Engineer II — Pharma Process Expert

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

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.