Healthcare staffing Pros LLC
Remote CSV Consultant Computer Systems Validation Expert
Healthcare staffing Pros LLC, Myrtle Point, Oregon, United States, 97458
Job Description
Job Description
**
Contract Duration: ** 3–6 Months
**
Compensation: ** $40/hour (Remote, W-2 or 1099)
**
Location: ** Remote
About the Role
We are seeking a
CSV Consultant (Computer Systems Validation Expert)
to support validation activities in regulated industries such medical devices, and biotechnology. The ideal candidate will be an experienced professional with a strong command of
FDA 21 CFR Part 11
,
GAMP 5
, and
GxP
requirements.
This role involves the full lifecycle of validation — from planning and
writing detailed validation protocols
to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance.
**
Key Responsibilities **
**
Plan, write, and review validation protocols ** and related documentation for computer systems.
Draft and maintain
test scripts
,
IQ/OQ/PQ protocols
, and
validation reports
.
Conduct and document
testing activities
to verify systems function as intended and meet all regulatory and business requirements.
Ensure
data integrity
and adherence to
FDA 21 CFR Part 11
,
GAMP 5
, and
GxP
standards.
Collaborate with
Quality Assurance, IT, and Regulatory Affairs
teams to maintain compliance and support internal and external audits.
Develop and maintain
validation documentation
, including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.
Support continuous improvement in validation and documentation processes.
**
Industries & Work Environments **
**
Pharmaceutical ** and
medical device manufacturing
**
Biotechnology ** and
life sciences
sectors
**
Clinical ** and
laboratory
environments
**
Required Skills & Qualifications **
Proven experience in
Computer Systems Validation (CSV)
within regulated industries.
Strong technical writing skills, especially in
protocol development and documentation
.
In-depth understanding of
quality assurance
,
quality control
, and
software validation
.
Working knowledge of
risk management
principles and validation methodologies.
Familiarity with
automation tools
and electronic systems (preferred but not required).
**
Why Join Us **
100%
remote position
with flexible scheduling.
Opportunity to collaborate with leaders in
life sciences
and
regulatory compliance
.
Engage in
mission-driven validation projects
that ensure patient safety and product quality.
**
To Apply: **
Please submit your resume and a brief summary of your validation and protocol writing experience, including systems or tools you’ve supported.
**
Contract Duration: ** 3–6 Months
**
Compensation: ** $40/hour (Remote, W-2 or 1099)
**
Location: ** Remote
About the Role
We are seeking a
CSV Consultant (Computer Systems Validation Expert)
to support validation activities in regulated industries such medical devices, and biotechnology. The ideal candidate will be an experienced professional with a strong command of
FDA 21 CFR Part 11
,
GAMP 5
, and
GxP
requirements.
This role involves the full lifecycle of validation — from planning and
writing detailed validation protocols
to executing tests, documenting outcomes, and ensuring systems maintain data integrity and regulatory compliance.
**
Key Responsibilities **
**
Plan, write, and review validation protocols ** and related documentation for computer systems.
Draft and maintain
test scripts
,
IQ/OQ/PQ protocols
, and
validation reports
.
Conduct and document
testing activities
to verify systems function as intended and meet all regulatory and business requirements.
Ensure
data integrity
and adherence to
FDA 21 CFR Part 11
,
GAMP 5
, and
GxP
standards.
Collaborate with
Quality Assurance, IT, and Regulatory Affairs
teams to maintain compliance and support internal and external audits.
Develop and maintain
validation documentation
, including validation plans, specifications, standard operating procedures (SOPs), and risk assessments.
Support continuous improvement in validation and documentation processes.
**
Industries & Work Environments **
**
Pharmaceutical ** and
medical device manufacturing
**
Biotechnology ** and
life sciences
sectors
**
Clinical ** and
laboratory
environments
**
Required Skills & Qualifications **
Proven experience in
Computer Systems Validation (CSV)
within regulated industries.
Strong technical writing skills, especially in
protocol development and documentation
.
In-depth understanding of
quality assurance
,
quality control
, and
software validation
.
Working knowledge of
risk management
principles and validation methodologies.
Familiarity with
automation tools
and electronic systems (preferred but not required).
**
Why Join Us **
100%
remote position
with flexible scheduling.
Opportunity to collaborate with leaders in
life sciences
and
regulatory compliance
.
Engage in
mission-driven validation projects
that ensure patient safety and product quality.
**
To Apply: **
Please submit your resume and a brief summary of your validation and protocol writing experience, including systems or tools you’ve supported.