Quality Validation Engineer

Quality Validation Engineer

Location: Swiftwater, PA



Work Arrangement: Onsite



Contract Duration: 12 Months



Pay Rate: Up to $95/hr on C2C



Interview Mode: Video



Vendor: Lenox



Candidate Location: Anywhere in the USA



Relocation: Accepted



Work Authorization: Open to all visa types



Submission Deadline: By EOD



Submission Slots: 2



LinkedIn Profile: Required



References: Mandatory 2 Professional References Required Position Overview

We are seeking an experienced Quality Validation Engineer with a strong background in pharmaceutical or biopharmaceutical manufacturing environments . The ideal candidate will have extensive experience supporting Quality Validation, Quality Systems, and Regulatory Compliance activities.

The successful candidate will be responsible for supporting and reviewing validation activities across equipment, processes, facilities, computerized systems, and associated documentation while ensuring compliance with applicable regulatory and quality standards.

Key Responsibilities

• Support Quality Validation activities within pharmaceutical or biopharmaceutical manufacturing environments.

• Provide quality oversight and support for validation activities, including:

  • Equipment Validation

  • Process Validation

  • Facility Validation

  • Computerized Systems Validation (CSV)

  • Validation Documentation Review

• Review and approve validation protocols, reports, and supporting documentation.

• Ensure validation activities comply with applicable GMP, FDA, QSR, and regulatory requirements .

• Support and maintain Quality Systems in alignment with company procedures and regulatory standards.

• Participate in investigations, deviations, and corrective actions as required.

• Support CAPA (Corrective and Preventive Action) activities and ensure appropriate documentation and follow-up.

• Work closely with Manufacturing, Engineering, Quality, Validation, and other cross-functional teams.

• Ensure all validation and quality activities are properly documented and maintained in accordance with established procedures.

• Support continuous improvement initiatives related to validation processes and Quality Systems.

• Ensure compliance with applicable pharmaceutical and biopharmaceutical manufacturing regulations and industry standards.

Required Qualifications

• Bachelor's Degree in Electrical Engineering or a related Engineering field.

• Master's Degree preferred.

• 7+ years of relevant experience in pharmaceutical or biopharmaceutical manufacturing environments.

• Strong experience in Quality Validation, Quality Systems, and Regulatory Compliance .

• Hands-on experience supporting validation activities involving:

  • Equipment

  • Processes

  • Facilities

  • Computerized Systems

  • Validation Documentation

• Strong knowledge and experience with:

  • CAPA

  • QSR

  • FDA Regulations

  • GMP Requirements

• Experience reviewing validation documentation, protocols, reports, and related quality records.

• Strong understanding of regulatory compliance requirements within the pharmaceutical or biotech manufacturing industry.

• Excellent documentation, analytical, problem-solving, and communication skills.

Must-Have Skills

• Quality Validation

• Quality Systems

• Regulatory Compliance

• Equipment Validation

• Process Validation

• Facility Validation

• Computerized Systems Validation (CSV)

• Validation Documentation Review

• CAPA

• QSR

• FDA Regulations

• GMP

• Pharmaceutical Manufacturing

• Biopharmaceutical / Biotech Manufacturing

Note: Candidates with strong experience in regulated pharmaceutical or biopharmaceutical manufacturing environments and hands-on expertise in Quality Validation and Regulatory Compliance will be highly preferred.