United Consulting Hub
Job Title
Validation Engineer (W2 Only – No C2C)
Rate:
Competitive / Based on Experience
Position Overview We are seeking a skilled
Validation Engineer
to support equipment, systems, and process validation activities in a
pharma, biotech, or medical device
manufacturing environment. The role requires hands‑on experience in
IQ/OQ/PQ execution , protocol development, and compliance with
GxP and FDA
regulations.
Key Responsibilities
Develop, review, and execute
validation protocols (IQ/OQ/PQ)
for equipment and systems.
Perform
equipment and process qualification
per
GxP, FDA, and ISO
standards.
Prepare and maintain
validation documentation, reports, and summaries .
Collaborate with
Engineering, QA, and Manufacturing
teams to ensure smooth validation execution.
Support
CAPA investigations , deviations, and change controls for validated systems.
Assist in
commissioning, qualification, and requalification
activities.
Qualifications
Bachelor’s degree
in Engineering, Life Sciences, or related field.
1–10 years
of validation experience in
pharma, biotech, or medical device
industries.
Hands‑on experience with
cleanroom equipment, process systems, or automated manufacturing lines .
Strong knowledge of
GMP, GAMP 5, FDA 21 CFR Part 11 , and
ISO
standards.
Excellent
documentation, communication, and organizational
skills.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Engineering, Quality Assurance, and Manufacturing
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
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Rate:
Competitive / Based on Experience
Position Overview We are seeking a skilled
Validation Engineer
to support equipment, systems, and process validation activities in a
pharma, biotech, or medical device
manufacturing environment. The role requires hands‑on experience in
IQ/OQ/PQ execution , protocol development, and compliance with
GxP and FDA
regulations.
Key Responsibilities
Develop, review, and execute
validation protocols (IQ/OQ/PQ)
for equipment and systems.
Perform
equipment and process qualification
per
GxP, FDA, and ISO
standards.
Prepare and maintain
validation documentation, reports, and summaries .
Collaborate with
Engineering, QA, and Manufacturing
teams to ensure smooth validation execution.
Support
CAPA investigations , deviations, and change controls for validated systems.
Assist in
commissioning, qualification, and requalification
activities.
Qualifications
Bachelor’s degree
in Engineering, Life Sciences, or related field.
1–10 years
of validation experience in
pharma, biotech, or medical device
industries.
Hands‑on experience with
cleanroom equipment, process systems, or automated manufacturing lines .
Strong knowledge of
GMP, GAMP 5, FDA 21 CFR Part 11 , and
ISO
standards.
Excellent
documentation, communication, and organizational
skills.
Seniority Level
Mid‑Senior level
Employment Type
Contract
Job Function
Engineering, Quality Assurance, and Manufacturing
Industries
Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Biotechnology Research
#J-18808-Ljbffr