Quality Validation Engineer

Techtrueup

$95K — $115K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Electrical Engineering or related field; Master's preferred.
  • 6+ years of experience in pharmaceutical/biopharmaceutical manufacturing environments.
  • Strong background in Quality Validation and Quality Systems.
  • Extensive experience in Regulatory Compliance, specifically with FDA, GMP, and QSR.
  • Experience in supporting validation activities across equipment, processes, facilities, and computerized systems.

Responsibilities

  • Support validation activities for equipment, processes, and facilities.
  • Conduct and document validation for computerized systems.
  • Review and ensure quality of validation documentation meets regulatory standards.
  • Implement CAPA processes within quality systems.
  • Maintain compliance with FDA and GMP regulations in manufacturing environments.

Benefits

  • Opportunities for professional development and certifications.
  • Collaborative work environment emphasizing quality and compliance.
  • Flexible work hours to promote work-life balance.
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.

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