Requirements
iso 13485
six sigma
adaptiv
bachelor's
gmp
iq/oq/pq
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
Information not given or found