Full Job Description
Please provide the complete job description received from the vendor or client. Seeking a Quality Validation Engineer with 6+ yrs experience in Pharma or Biotech MANUFACTURING industries. Must have strong background in Quality Validation, Quality Systems and Regulatory Compliance.
REQUIREMENTS:
Bachelor's degree - Master's degree preferred.
6+years of experience in the pharmaceutical or biopharmaceutical manufacturing environments.
Strong background in quality validation, quality systems, and regulatory compliance
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Expertise with CAPA, QSR, FDA, GMP
Important Do not provide AI-generated summaries or short 1-2 line descriptions. Include the original responsibilities, required qualifications, technical skills, domain experience, and any client-specific requirements. Seeking a Quality Validation Engineer with 6+ yrs experience in Pharma or Biotech MANUFACTURING industries. Must have strong background in Quality Validation, Quality Systems and Regulatory Compliance.
Must-have skills
Years of experience required 7Years
Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
Education required QUALIFICATIONS Education Level Bachelor's Degree in Electrical Engineering or related Engineering field
Job Description
The vendor/client is seeking a Quality Validation Engineer with 6+ years of experience in pharmaceutical or biopharmaceutical manufacturing industries.
The candidate must have a strong background in Quality Validation, Quality Systems, and Regulatory Compliance.
The position requires experience supporting validation activities across:
Equipment validation
Process validation
Facility validation
Computerized systems validation
Validation documentation
Documentation review
The candidate should also have strong experience with quality and regulatory requirements, including:
CAPA
QSR
FDA requirements
GMP requirements
Quality Systems
Regulatory Compliance
Quality Validation
The candidate should have experience working within pharmaceutical or biopharmaceutical manufacturing environments, rather than purely laboratory, research, or non-manufacturing environments.
Qualifications
Education
Required:
Bachelor's Degree
Bachelor's Degree in Electrical Engineering or related Engineering field
Preferred:
Master's Degree
Professional Experience
Required:
6+ years of experience in pharmaceutical or biopharmaceutical manufacturing environments
Must-have requirement specifies 7 years of experience
Strong experience in Quality Validation
Strong experience with Quality Systems
Strong experience with Regulatory Compliance
Additional Information
All your information will be
The candidate must have experience supporting validation activities involving multiple areas:
Equipment Validation
Equipment qualification/validation
Supporting equipment validation activities
Validation documentation and review
Process Validation
Process validation activities
Manufacturing process validation
Supporting validation execution and documentation
Facility Validation
Facility validation
Manufacturing facility-related qualification/validation activities
Computerized Systems Validation
Computerized systems validation
Validation documentation
Quality review of computerized systems validation activities
Documentation Review
Review of validation documentation
Quality documentation review
Ensuring documentation meets applicable GMP and regulatory requirements
5. Quality Systems Experience
Strong Quality Systems experience is required.
Key areas include:
CAPA
Quality Systems
Quality documentation
Documentation review
Regulatory compliance
GMP compliance
FDA requirements
QSR requirements
The candidate should be comfortable working within a regulated pharmaceutical/biopharmaceutical manufacturing quality environment.
6. Regulatory / Compliance Experience
Must Have
FDA
GMP
QSR
Regulatory Compliance
Quality Systems
Quality Validation
The candidate should understand how validation activities are performed and documented within a regulated manufacturing environment.