Quality Engineer 

Location
Seattle, WA, United States
Posted
Jul 19, 2019
Ref
304198762
Discipline
Quality, Quality Control
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Just is seeking a highly-motivated Quality Engineer that desires to be part of a team focused on improving worldwide access to Biotherapeutics by supporting GMP plant operations. This individual will join the Quality team at Just with their primary responsibility of providing Quality oversight for the equipment, facilities, and utilities program along with supporting clinical process changes and their impact.

Responsibilities:
• Evaluate and enhance the equipment management program at Just.
• Provide Quality oversight to quality risk management documentation and equipment facilities utilities qualification for a process transfer from development to Phase I/II clinical drug substance manufacturing
• Mentor manufacturing and development groups in qualification/validation technical aspects, and compliance requirements
• Support the maintenance program at Just by reviewing and approving equipment calibration and preventative maintenance documents
• Define and implement maintenance and calibration procedures to support equipment at Just.
• Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates
• Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance

Requirements:
• Bachelor's degree in biological sciences, chemistry, biochemistry, engineering or related life science field
• 5 - 7+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment

Preferred Qualifications:
• Strong focus on quality and attention to detail
• GMP and compliance knowledge and experience with equipment qualification and validation in a cGMP manufacturing setting
• Previous experience working in upstream and/or downstream drug substance manufacturing
• Excellent verbal and written communication skills
• Experience working in a EQMS (Enterprise Quality Management Software) or EDMS (Electronic Document Management Software)
• Ability to work independently and be self-directed
• Ability to work in a dynamic environment with the ability to shift focus and priorities and work on a broad range of tasks simultaneously

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. Just is developing a portfolio of molecules that best leverages our technological strengths. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.