Process Engineer

Process Engineer at TSR Consulting Process Engineer at TSR Consulting in Woodinville, Washington Posted in 11 days ago.

Type:

full-time

Job Description:

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Job Title:

Senior Specialist - MSAT Process Engineering ???? Bothell, WA (Onsite) ???? $60/hr (W2) ????

Schedule:

Monday-Friday, Standard Business Hours ???? About the Role We are seeking a Senior Specialist - MSAT Process Engineering to support manufacturing operations in a regulated biotech environment. This is a technical liaison role where you will collaborate across Manufacturing, MSAT, Quality, and IT teams to drive process improvements, support tech transfer activities, and ensure efficient production workflows. This role is ideal for candidates who understand biologics or cell therapy manufacturing and enjoy working at the intersection of process engineering and systems/project coordination . ???? Key Responsibilities Support MSAT (Manufacturing Science & Technology) activities for biologics/cell therapy manufacturing Act as a cross-functional liaison between Manufacturing, Quality, MSAT, and IT teams Assist in tech transfer, process optimization, and scale-up activities Analyze manufacturing data to support yield improvement and process efficiency Participate in root cause investigations (RCA), deviations, and CAPA activities Support and interact with manufacturing systems (MES - Syncade preferred) Gather and document business/technical requirements and support system enhancements Ensure compliance with GMP/cGMP regulations and quality standards ? Top Required Skills 1.

Biologics / Cell

Therapy Manufacturing Knowledge Experience in GMP/cGMP regulated environments Exposure to cleanroom operations, aseptic processing, batch records (EBR) Understanding of upstream/downstream processes 2.

Project / Systems

Coordination Skills Experience with cross-functional collaboration (Manufacturing, IT, Business teams) Familiarity with requirements gathering, SDLC, user stories, or data mapping Ability to manage timelines and coordinate technical activities 3. MSAT / Process Improvement Experience Exposure to tech transfer, process optimization, or scale-up Experience with root cause analysis (RCA), CAPA, continuous improvement Familiarity with MES systems (Syncade preferred)