Downstream Manufacturing Associate III/Senior (WA)

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

JOB SUMMARY

The Downstream Manufacturing Associate performs basic to advanced bioprocess operations such as (filtration, protein purification, chromatography/separation, viral inactivation/UFDF, bulk fill) as well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, and operation). This role executes daily tasks in accordance with the Master and Finite schedules to meet site objectives, deliverables, and customer commitments.

Manufacturing Associates work in either Upstream or Downstream teams and execute batch records, run, and monitor equipment, monitor production processes, and complete documentation in line with cGMP (current good manufacturing practices) and GDP (good documentation procedures). In their daily tasks, Manufacturing Associates always observe and follow safety procedures and Standard Operating Procedures (SOPs). Additionally, Manufacturing Associates work cross-functionally with QA, MSAT, Facilities, and other key departments to ensure ongoing manufacturing operations are successful, reliable, safe, and compliant. 

• An Associate III executes basic to intermediate bioprocess operations independently as a Qualified Verifier and supports advanced bioprocessing operations under guidance.
• An Associate Senior leads basic to advanced bioprocess operations as a Qualified Verifier.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES – Associate III

• Execute basic to intermediate bioprocess operations independently as a Qualified Verifier and support advanced bioprocessing operations under guidance.
• Safely set-up and operate manufacturing equipment.
• Prepare, program, monitor, and read outputs of analytical equipment.
• Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP.
• Analyze issues and make decisions within defined parameters to resolve a wide range of issues in creative ways. Escalate as needed.
• Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.).
• Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations.
• Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and repairs.
• Attend and actively participate in daily Tier 0 shift change meetings.
• Maintain a clean and safe work environment to ensure audit readiness at all times; practicing LEAN principles. Report safety observations in a timely manner.
• Complete assigned trainings and qualifications as required and seek opportunities for continual learning. Train less experienced team members on basic to intermediate processes and procedures.
• Qualified Trainer on basic to intermediate operations.
• Support projects, initiatives, and team goals by delivering on all assigned tasks.
• Execute additional manufacturing activities and process support with other manufacturing groups and cross functional partners to support continuous improvement of the value stream.
• Recommend and execute projects and process improvements to reduce risk and increase efficiency.
• Contributes to a culture of teamwork, compliance and positive behaviors and attitudes.

ESSENTIAL JOB DUTIES/RESPONSIBILITIES – Associate Sr.

• Safely set-up and operate manufacturing equipment.
• Prepare, program, monitor, and read outputs of analytical equipment.
• Read and execute Batch Records using SOPs for operations processes as directed, adhering to cGMP.
• Independently analyze issues, troubleshoot, and solve highly complex problems providing and executing innovative solutions. Escalate as needed.
• Document, record, and review cGMP data in real time and guide other operators in properly completing batch records, logbooks, and in-process data. Assist with creation, review, and revision of GMP documentation (SOPs, Batch Records, Work Instructions etc.). May initiate CAPAs or Change Controls if trained.
• Support investigations by responding to inquiries in a timely manner. Initiates Deviations. May own minor investigations.
• Perform routine cleaning and preventative maintenance of equipment to ensure process readiness. Submit work orders for maintenance and rep