Manufacturing Associate I - Bothell WA

Military Spouse Corporate Career Network•Bothell, WA

1d•Onsite

About The Position

The Manufacturing Associate I supports routine cell therapy manufacturing operations and contributes to cell therapy programs. The role requires working effectively on a team while maintaining safety, quality, and Good Manufacturing Practice (GMP) compliance. Associates learn and carry out manufacturing operations, follow governing documents and electronic processes, complete required documentation and training, and may work in cleanroom environments and perform assigned aseptic processing. The position is onsite in Bothell, Washington. Available schedules include day and swing shifts across specified days, with possible alternate Wednesdays.

Requirements

High school diploma or equivalent combination of education and experience.
0–1 years of cGMP cell therapy manufacturing, bioprocessing manufacturing, or relevant experience and education.
Demonstrated experience working on teams where collaboration and results were expected.
Proficiency with common computer tools, including word-processing, spreadsheet, and web-based applications.
Meticulous attention to detail and personal accountability.
Excellent interpersonal skills; attentive and approachable demeanor.
Ability to maintain professional and productive relationships with area management and coworkers.
Ability to stand and walk for extended periods.
Ability to work in a cleanroom and perform assigned aseptic processing in ISO 5 biosafety cabinets while wearing required gowning and PPE.
Ability to carry and/or lift up to 30 pounds several times a day and push and/or pull up to 50 pounds several times a day.
Ability to work in areas with strong magnets, in a BSL2 / ML1 environment handling human blood components, and in areas exposed to vapor-phase liquid nitrogen.
Ability to work an assigned day, evening, or night shift, including weekends and/or holidays.

Nice To Haves

U.S. associate or bachelor's degree in a related field.
Basic understanding of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Responsibilities

Learn and execute cell therapy manufacturing operations compliantly.
Follow Source Governing Documents, including Standard Operating Procedures, Work Instructions, Batch Records, and Forms.
Execute transactions and processes in electronic systems and adhere to business continuity processes.
Prioritize personal and others' safety, report safety events within 24 hours, and immediately escalate issues that may affect safety or compliance.
Complete required documentation contemporaneously and follow safety policies, SOPs, quality systems, GMP requirements, and ALCOA+ principles.
Complete assigned training before due dates and verify training completion before performing GxP tasks.
Train to proficiency in process systems and some supporting business systems.
Execute the daily unit operations schedule, coordinating people, product, and material flow across multiple shifts.
Work in a controlled cleanroom and perform assigned aseptic processing procedures.
Maintain manufacturing environmental conditions by performing required area disinfection to meet controlled-area specifications and global Health Authority requirements.
Refine manufacturing techniques to improve individual operational times.
Author technically sound manufacturing operating procedures that promote effective and efficient operations and comply with cGMP requirements.