Validation Engineer

Description

• Independently handle all aspects of validation documentation and execution, including development of IQ, OQ, and PQ documentation.
• Author PQ validation completion reports upon successful completion.
• Manage multiple complex validation projects simultaneously from initiation through completion.
• Ensure compliance with relevant medical device/pharma regulations and quality systems.
• Execute detailed and technical PQ validations per client requirements and standards.
• Create detailed IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
• Generate equipment and fixture matrices for MVP, including qualification requirements as defined by the medical device company.
• Provide technical expertise to develop and implement Standard Operating Procedures (SOPs) for newly validated processes and laboratory equipment.
• Troubleshoot issues using root cause analysis, structured problem-solving, and implement effective corrective actions (CAPA) while following GMP requirements.
• Author validation completion reports upon successful IQ/OQ completion.
• Execute detailed and technical IQ/OQ validation protocols aligned with client requirements and applicable standards.

Requirements

Experience with Validation and ISO 13485, with demonstrated knowledge of FDA and MDD GMP requirements related to Medical Devices or Pharm.

**BEPC does not accept C2C, C2H, or W2 referral applications. **

BEPC has an open position for a Validation Engineer

Requirements: 3+ years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry.

• 3+ years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry.
• Experience with Validation and ISO 13485, with demonstrated knowledge of FDA and MDD GMP requirements related to Medical Devices or Pharma.
• Six Sigma Green Belt or Black Belt training/certification.
• Cross-functional collaboration and clear communication
• Must be able to speak, read, comprehend, and write English.
• Knowledge of GD&T and Statistical Engineering Qualification.
• GMP mindset with compliance-focused execution
• Validation lifecycle expertise (IQ/OQ/PQ) and strong technical writing
• Bachelor’s degree (or higher) in a Science or Engineering discipline.
• Familiarity with J&J validation methodology.
• Problem-solving, troubleshooting, and root cause analysis
• Experience with change documentation management using Adaptiv.
• Strong organizational skills and ability to manage multiple projects

Benefits

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $60-$65 per hour (Paid Weekly)

Training + Development

Interview process

Visa Sponsorship

Security clearance