Process Engineering Positions

Role Overview Upstream Process Engineer II - Redmond, WA. Reports to the Senior Manager, Upstream Process Engineering.
Responsibilities Represent Site MSAT on project teams as technical subject‑matter expert (SME) and interface with Global MSAT, Operations, and Quality functions.
author, review, and own process documentation (technical documents, test protocols, batch records, process descriptions, SOPs, etc.).
Lead change controls and manage implementation as the assigned change agent.
Partner with Manufacturing to produce high‑quality batch records, robust processes, and innovative technology solutions.
Participate in or lead investigations related to process or new product implementation.
Collaborate with impacted groups to drive CAPA implementation from approval to closure and effectiveness checks.
Participate in quality and technical risk assessment activities.
Support technology transfer or new production introduction activities.
Monitor and report on process performance data analysis.
Partner with Validation and Quality groups to support equipment onboarding and periodic review programs as process owners.
Provide 24/7 on‑call support during production.
Apply Operational Excellence principles to lead continuous improvement for upstream process improvements.
Qualifications Bachelor’s degree in Engineering with 2-4 years of pharmaceutical/biotech experience, or a master’s degree in engineering with >1 year of experience.
Experience supporting process transfer / technology transfer projects and teams in the biopharmaceutical industry; commercial manufacturing campaign support is a plus.
Solid understanding of upstream processing, including hands‑on experience in single‑use bioreactor operations and perfusion technology at manufacturing scale or in process development of biologics.
Solid understanding of GMP concepts and quality systems necessary to support manufacturing and new product introduction activities.
Working knowledge of manufacturing process equipment and automation systems.
Ability to organize, analyze, and communicate process data effectively.
Strong focus on quality, attention to detail, and effective task/time‑management and organizational skills.
Excellent verbal and written communication skills in English; Preferred Qualifications Ability to navigate regulatory CMC documents.
Experience supporting late‑stage manufacturing, technical transfer, and process validation studies.
Experience supporting audits and inspections by health authorities, clients, and external auditors as a presenter or audit support staff.
Discretionary annual bonus.
Medical, dental, and vision coverage.
Short‑term and long‑term disability.
Company‑paid basic life insurance.
Flexible work options.
Generous paid time off and paid holidays.
All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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