Quality Validation Engineer

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.

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