Barrington James
Consultant at Barrington James | Engineering and Manufacturing - USA
Barrington James is supporting a
rapidly expanding biotech manufacturing site
in the Seattle area seeking
Commissioning, Qualification, and Validation (CQV) Engineers
to support ongoing
process equipment and utility system qualifications
during a critical expansion phase.
This is an excellent opportunity for validation professionals who thrive in
hands-on, fast-paced, GMP environments
and are ready to join one of the region’s most active biotech buildouts.
Responsibilities
Develop and execute
IQ/OQ/PQ
protocols for process, utility, and support systems.
Support qualification and validation activities for
bioreactors, chromatography skids, filtration systems, SUBs, SUMs (100L–2000L) , autoclaves, incubators, and
clean utilities (WFI, PW, HVAC, compressed gases) .
Author and review validation documentation —
Validation Plans, Risk Assessments, Traceability Matrices, Summary Reports, and URS .
Perform
EMPQ and temperature mapping
using Ellab/Kaye validators.
Utilize
electronic validation platforms (Kneat Gx, ValGenesis, or equivalent)
for documentation and execution.
Collaborate with
Quality, Automation, Engineering, and Facilities
teams to ensure alignment with GMP requirements and project timelines.
Drive deviation documentation, CAPA resolution, and change control support for validation deliverables.
Requirements
Bachelor’s degree
in Engineering, Life Sciences, or related discipline.
3–10 years
of CQV or validation experience in
biotech, pharmaceutical, or CDMO manufacturing
environments.
Proven experience qualifying
bioprocess and clean utility systems
in accordance with FDA and cGMP standards.
Strong working knowledge of
21 CFR Part 11, GAMP 5, ASTM E2500 , and
data integrity principles .
Experience with
Kneat Gx or ValGenesis
preferred.
Must have prior experience performing
EMPQ (Environmental Monitoring / Equipment Performance Qualification) .
Seniority level:
Mid-Senior level
Employment type:
Contract
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
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rapidly expanding biotech manufacturing site
in the Seattle area seeking
Commissioning, Qualification, and Validation (CQV) Engineers
to support ongoing
process equipment and utility system qualifications
during a critical expansion phase.
This is an excellent opportunity for validation professionals who thrive in
hands-on, fast-paced, GMP environments
and are ready to join one of the region’s most active biotech buildouts.
Responsibilities
Develop and execute
IQ/OQ/PQ
protocols for process, utility, and support systems.
Support qualification and validation activities for
bioreactors, chromatography skids, filtration systems, SUBs, SUMs (100L–2000L) , autoclaves, incubators, and
clean utilities (WFI, PW, HVAC, compressed gases) .
Author and review validation documentation —
Validation Plans, Risk Assessments, Traceability Matrices, Summary Reports, and URS .
Perform
EMPQ and temperature mapping
using Ellab/Kaye validators.
Utilize
electronic validation platforms (Kneat Gx, ValGenesis, or equivalent)
for documentation and execution.
Collaborate with
Quality, Automation, Engineering, and Facilities
teams to ensure alignment with GMP requirements and project timelines.
Drive deviation documentation, CAPA resolution, and change control support for validation deliverables.
Requirements
Bachelor’s degree
in Engineering, Life Sciences, or related discipline.
3–10 years
of CQV or validation experience in
biotech, pharmaceutical, or CDMO manufacturing
environments.
Proven experience qualifying
bioprocess and clean utility systems
in accordance with FDA and cGMP standards.
Strong working knowledge of
21 CFR Part 11, GAMP 5, ASTM E2500 , and
data integrity principles .
Experience with
Kneat Gx or ValGenesis
preferred.
Must have prior experience performing
EMPQ (Environmental Monitoring / Equipment Performance Qualification) .
Seniority level:
Mid-Senior level
Employment type:
Contract
Industries:
Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr