Quality Validation Engineer

Company Description

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

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.

kept confidential according to EEO guidelines.