United Pharma Technologies Inc
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Computer System Validation (CSV) Engineer Location:
North Carolina (Onsite)
Position Overview:
We are seeking an experienced
Computer System Validation (CSV) Engineer
to support validation and compliance initiatives across the digital landscape. The ideal candidate will have strong expertise in
Data Integrity ,
Change Control ,
Deviation Management , and
Validation
processes, ensuring systems and processes adhere to regulatory and quality standards.
Key Responsibilities
Develop, review, and execute CSV deliverables in alignment with
GAMP 5
and
ALCOA+
principles.
Ensure compliance with data integrity requirements across computerized systems.
Support and maintain
change control ,
deviation , and
CAPA
activities related to validated systems.
Collaborate with Quality, IT, and Engineering teams to ensure validation activities meet regulatory expectations (FDA, EMA, etc.).
Author and execute
Validation Plans ,
Risk Assessment ,
IQ/OQ/PQ protocols , and
Summary Reports .
Provide oversight and guidance on CSV lifecycle management and system upgrades.
Participate in audits and inspections, ensuring readiness and compliance with GxP standards.
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, or a related scientific discipline.
5+ years of experience
in
Computer System Validation (CSV)
within a regulated industry (pharmaceutical, biotech, or medical device).
Proven experience in
Data Integrity ,
Change Control , and
Deviation Management .
Strong knowledge of
GAMP 5 ,
ALCOA+ ,
21 CFR Part 11 , and
Annex 11
compliance requirements.
Excellent documentation and communication skills.
Employment Details
Seniority level:
Mid‑Senior
Employment type:
Contract
Industry:
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at United Pharma Technologies Inc by 2x
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Direct message the job poster from United Pharma Technologies Inc
Computer System Validation (CSV) Engineer Location:
North Carolina (Onsite)
Position Overview:
We are seeking an experienced
Computer System Validation (CSV) Engineer
to support validation and compliance initiatives across the digital landscape. The ideal candidate will have strong expertise in
Data Integrity ,
Change Control ,
Deviation Management , and
Validation
processes, ensuring systems and processes adhere to regulatory and quality standards.
Key Responsibilities
Develop, review, and execute CSV deliverables in alignment with
GAMP 5
and
ALCOA+
principles.
Ensure compliance with data integrity requirements across computerized systems.
Support and maintain
change control ,
deviation , and
CAPA
activities related to validated systems.
Collaborate with Quality, IT, and Engineering teams to ensure validation activities meet regulatory expectations (FDA, EMA, etc.).
Author and execute
Validation Plans ,
Risk Assessment ,
IQ/OQ/PQ protocols , and
Summary Reports .
Provide oversight and guidance on CSV lifecycle management and system upgrades.
Participate in audits and inspections, ensuring readiness and compliance with GxP standards.
Required Qualifications
Bachelor’s degree in Engineering, Computer Science, or a related scientific discipline.
5+ years of experience
in
Computer System Validation (CSV)
within a regulated industry (pharmaceutical, biotech, or medical device).
Proven experience in
Data Integrity ,
Change Control , and
Deviation Management .
Strong knowledge of
GAMP 5 ,
ALCOA+ ,
21 CFR Part 11 , and
Annex 11
compliance requirements.
Excellent documentation and communication skills.
Employment Details
Seniority level:
Mid‑Senior
Employment type:
Contract
Industry:
Pharmaceutical Manufacturing and Biotechnology Research
Referrals increase your chances of interviewing at United Pharma Technologies Inc by 2x
#J-18808-Ljbffr