Process Engineer
TSR Consulting, Bothell, WA, United States
Senior Specialist – MSAT Process Engineering
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.
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
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
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
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)
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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.
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
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
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
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)
#J-18808-Ljbffr