Manufacturing Associate (Onsite)

Partner Therapeutics•Lynnwood, WA

1d•Onsite

About The Position

Manufacturing Associates are involved in cleaning and sterilization of process equipment, autoclaving, buffer preparation, aseptic processing, operating process equipment and supporting cGMP operations. Downstream staff focuses on HPLC and low-pressure Chromatography equipment. This position is an ONSITE role requiring a presence 5 days per week at our Lynnwood, WA plant.

Requirements

Ability and willingness to wear a respirator and other PPE for multiple consecutive hours while meeting compliance and safety guideline to complete certain tasks.
Ability and willingness to work with strong acids, bases, and other solvents required for the job (PPE utilized).
Effectively demonstrates an understanding of GMPs and strictly follows cGMP requirements and standards.
Possess problem solving skills
Utilize manufacturing knowledge to improve operations and affect positive change
Self-motivated and take initiative to complete tasks
Ability to be flexible with change
Solid English language skills, both verbal and written.
Ability to write clear and concise procedure documents; is able to clearly expresses ideas, opinions, and questions.
Proficiency with MS Office products, especially Microsoft Word.
High School Diploma or GED
3+ years of experience in a cGMP manufacturing environment or other comparable experience (i.e., other regulated industry)
Prolonged walking and/or standing.
Lifting 15 kilograms (30 pounds) successfully without assistance.
PPE required including prolonged use of a fitted respirator.
Ability to meet PTx gowning requirements to work in a Grade C/D cleanroom (ISO class 7/8).
Ability to work with strong acids, bases, and other solvents required for the job (PPE utilized).
Some seated work in front of video monitors.

Nice To Haves

Experience in Downstream experience (HPLC and low-pressure Chromatography)
Associate degree, BA or BS in a science-related field or Engineering Field.

Responsibilities

Operates process equipment such as chromatography systems in accordance with established Standard Operation Procedures (“SOP”s).
Operates support equipment such as autoclaves, buffer preparation equipment in accordance with established SOPs.
Performs clean-in-place and steam-in-place operations to prepare equipment for manufacturing operations in accordance with established SOPs.
Identifies and troubleshoots routine issues and defects with assistance from higher level co-workers or SMEs.
Performs routine maintenance on process equipment and systems.
Assists in the review and creation of SOPs and other operational documents.
Maintains fit and finish of process area.
Practices safe work habits and adheres to Partner’s safety procedures and guidelines.
May train new team members as appropriate.