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Overview
The Process Validation Engineer is responsible for planning, executing, and documenting process validation activities to ensure that manufacturing processes consistently produce products meeting quality and regulatory requirements (FDA, GMP, ISO 13485). The role involves working cross-functionally with Manufacturing, Quality, and R&D teams to support new product introductions, process improvements, and ongoing validation maintenance. Key Responsibilities
Develop and execute
Process Validation (PV) protocols
(IQ/OQ/PQ) in compliance with regulatory standards. Support
Equipment Qualification
and
Cleaning Validation
as needed. Conduct
risk assessments
(FMEA) and establish critical process parameters and acceptance criteria. Perform
data analysis
and summarize validation results with clear conclusions and recommendations. Prepare and maintain
validation documentation , reports, and master plans. Collaborate with manufacturing and quality teams to identify and resolve process issues. Ensure compliance with
cGMP ,
FDA ,
ISO 13485 , and company validation policies. Support
change control
and
CAPA
processes related to validated systems. Participate in internal and external audits by providing validation documentation and responses. Required Qualifications
Bachelor’s degree in
Engineering (Mechanical, Chemical, Biomedical, or related field)
or equivalent. 3 years
of experience in
process validation
within the
pharmaceutical or medical device
industry. Strong knowledge of
cGMP ,
FDA 21 CFR Part 820 , and
ISO 13485
regulations. Hands-on experience with
validation protocols ,
test execution , and
statistical analysis . Proficiency in tools like
Minitab ,
Excel , or other data analysis software. Excellent technical writing, communication, and organizational skills. Thanks Suchi suchi@vastekgroup.com
#J-18808-Ljbffr
The Process Validation Engineer is responsible for planning, executing, and documenting process validation activities to ensure that manufacturing processes consistently produce products meeting quality and regulatory requirements (FDA, GMP, ISO 13485). The role involves working cross-functionally with Manufacturing, Quality, and R&D teams to support new product introductions, process improvements, and ongoing validation maintenance. Key Responsibilities
Develop and execute
Process Validation (PV) protocols
(IQ/OQ/PQ) in compliance with regulatory standards. Support
Equipment Qualification
and
Cleaning Validation
as needed. Conduct
risk assessments
(FMEA) and establish critical process parameters and acceptance criteria. Perform
data analysis
and summarize validation results with clear conclusions and recommendations. Prepare and maintain
validation documentation , reports, and master plans. Collaborate with manufacturing and quality teams to identify and resolve process issues. Ensure compliance with
cGMP ,
FDA ,
ISO 13485 , and company validation policies. Support
change control
and
CAPA
processes related to validated systems. Participate in internal and external audits by providing validation documentation and responses. Required Qualifications
Bachelor’s degree in
Engineering (Mechanical, Chemical, Biomedical, or related field)
or equivalent. 3 years
of experience in
process validation
within the
pharmaceutical or medical device
industry. Strong knowledge of
cGMP ,
FDA 21 CFR Part 820 , and
ISO 13485
regulations. Hands-on experience with
validation protocols ,
test execution , and
statistical analysis . Proficiency in tools like
Minitab ,
Excel , or other data analysis software. Excellent technical writing, communication, and organizational skills. Thanks Suchi suchi@vastekgroup.com
#J-18808-Ljbffr