Manufacturing Associate III - Day Shifts, Site Based Redmond, WA

Role Summary

Manufacturing Associate III based in Redmond, WA, on a day-shift schedule (Wednesday–Saturday, 07:00–18:00). The role executes process recipes, monitors equipment and processes, and performs basic tasks including sampling and routine maintenance to support downstream manufacturing operations. They follow safety requirements, cGMP practices, SOPs, and manufacturing documentation, and may assist with media and buffer compounding. The role emphasizes curiosity, problem-solving, and collaboration to improve processes.

Responsibilities

• Perform and monitor critical processes (e.g., column packing, capture and polishing chromatography, viral inactivation, viral filtration, and UF/DF operations).
• Support the introduction of new products and technologies into the facility.
• Initiate quality records, including non-conformances (NC), Corrective/Preventive Actions (CAPA), and assisting in investigations.
• Draft and revise Manufacturing Procedures and Standard Operating Procedures as necessary.
• With minimal supervision, set up, operate, and maintain a majority of manufacturing equipment; collect data, and write/update GMP documentation.
• With direction from Floor Lead/Supervisor, propose and test solutions to manufacturing operational problems. Be able to identify when a deviation has occurred.
• Actively participate in departmental teams, NPI. May present run data as applicable.
• Train junior level staff.
• Respond to equipment alarms with help of Floor Lead.
• Effectively communicate with Floor Lead/Supervisor the status of manufacturing operations.
• Document operational requirements in batch records in accordance with cGMP and company guidelines.
• Develop an understanding of equipment and operations used to manufacture biotherapeutics in a cGMP manner.
• Demonstrate situational leadership within manufacturing and company responsibilities.
• Perform other duties as assigned.

Qualifications

• Required: Master’s degree; or Bachelor’s degree and 3 years of Manufacturing & Operations experience; or Associate’s degree and 5 years of Manufacturing & Operations experience; or High school diploma / GED and 7 years of Manufacturing & Operations experience.
• Preferred: Single-use technology experience.
• Preferred: Capacity to develop solutions to technical issues of moderate scope.
• Preferred: Train other personnel on equipment operation.
• Preferred: Draft and revise SOPs.
• Preferred: Proven knowledge of cGMP requirements to ensure compliance.
• Preferred: Experience in operations required for the manufacture of biotherapeutics.
• Preferred: Focus on quality and attention to detail.
• Preferred: Ability to organize, analyze/interpret, and effectively communicate data and results.
• Preferred: Motivated, self-starter with strong mechanical aptitude.
• Preferred: Good interpersonal, team, and communication skills.
• Preferred: Troubleshooting skills on manufacturing equipment including single-use equipment.
• Preferred: Experience with DeltaV/MES.
• Preferred: Experience with lab equipment/testing.
• Preferred: Be open to change and manage emotions during periods of organizational change.