United Pharma
Validation Engineer (Computer System Validation (CSV))
United Pharma, Olympia, Washington, United States
Location:
WA (Onsite)
Duration:
17-Month Contract
Key Responsibilities
Execute
Computer System Validation (CSV)
activities for GMP manufacturing systems, including protocol development and execution ( IQ, OQ, PQ ).
Validate computerized systems associated with
bioprocess manufacturing equipment , including:
Bioreactors
(stainless steel and single-use)
Single-Use Bioreactors (SUB)
and
Single-Use Mixers (SUM)
Upstream and downstream process skids
(TFF, UF/DF, chromatography, filtration, buffer preparation)
Process analyzers and analytical instruments
integrated with manufacturing operations
CIP/SIP systems
with electronic and automated controls
Support validation of automation and control interfaces, including
DeltaV, PLC-based systems, and MES .
Ensure compliance with
cGMP regulations, 21 CFR Part 11, and data integrity requirements .
Collaborate closely with Manufacturing, Automation, Engineering, and Quality teams during onsite execution.
Participate in deviation investigations, change control, and remediation activities related to validated systems.
Provide support during internal audits and regulatory inspections as a CSV subject matter expert.
Required Qualifications
Proven experience as a
CSV Engineer
supporting
GMP biologics manufacturing environments .
Hands‑on validation experience with
computerized manufacturing equipment and automation systems .
Strong knowledge of
21 CFR Part 11 , data integrity, and regulatory expectations for computerized systems.
Experience executing
IQ/OQ/PQ onsite
in active manufacturing facilities.
Familiarity with automation platforms such as
DeltaV, PLCs, and MES .
Ability and willingness to
relocate and work onsite in Seattle
for the duration of the contract.
This is not a QC laboratory CSV role.
Candidates must have direct experience validating
manufacturing equipment and associated software systems
in a bioprocessing or biologics production environment.
Seniority level Mid‑Senior level
Employment type Contract
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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WA (Onsite)
Duration:
17-Month Contract
Key Responsibilities
Execute
Computer System Validation (CSV)
activities for GMP manufacturing systems, including protocol development and execution ( IQ, OQ, PQ ).
Validate computerized systems associated with
bioprocess manufacturing equipment , including:
Bioreactors
(stainless steel and single-use)
Single-Use Bioreactors (SUB)
and
Single-Use Mixers (SUM)
Upstream and downstream process skids
(TFF, UF/DF, chromatography, filtration, buffer preparation)
Process analyzers and analytical instruments
integrated with manufacturing operations
CIP/SIP systems
with electronic and automated controls
Support validation of automation and control interfaces, including
DeltaV, PLC-based systems, and MES .
Ensure compliance with
cGMP regulations, 21 CFR Part 11, and data integrity requirements .
Collaborate closely with Manufacturing, Automation, Engineering, and Quality teams during onsite execution.
Participate in deviation investigations, change control, and remediation activities related to validated systems.
Provide support during internal audits and regulatory inspections as a CSV subject matter expert.
Required Qualifications
Proven experience as a
CSV Engineer
supporting
GMP biologics manufacturing environments .
Hands‑on validation experience with
computerized manufacturing equipment and automation systems .
Strong knowledge of
21 CFR Part 11 , data integrity, and regulatory expectations for computerized systems.
Experience executing
IQ/OQ/PQ onsite
in active manufacturing facilities.
Familiarity with automation platforms such as
DeltaV, PLCs, and MES .
Ability and willingness to
relocate and work onsite in Seattle
for the duration of the contract.
This is not a QC laboratory CSV role.
Candidates must have direct experience validating
manufacturing equipment and associated software systems
in a bioprocessing or biologics production environment.
Seniority level Mid‑Senior level
Employment type Contract
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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