Quality Validation Engineer
Detailed 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
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.
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
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.
kept confidential according to EEO guidelines.