Validation Engineer; Medical Industry

Position and Location

Santa Clara, CA –
Validation Engineer

BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

Direct message the job poster from BEPC Inc.

- Business Excellence Professional Consulting.

$60.00/hr – $65.00/hr

• Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
• Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
• Execute detailed, technical IQ/OQ validation protocols for medical device manufacturing and laboratory settings, in line with client requirements and standards.
• Upon successful completion of IQ/OQ validations, author validation completion reports.
• Execute detailed and technical PQ validations as per client requirements and standards.
• Successful completion of PQ validations and author validation completion reports.
• Provide technical expertise and support to develop and implement all associated Standard Operating Procedures for newly validated medical device processes and laboratory equipment.
• Demonstrate experience in troubleshooting, root cause analysis, problem‑solving, implementing effective corrective actions, and following GMP requirements to ensure compliance with all medical device regulations.
• Manage multiple complex validation projects on laboratory equipment simultaneously, from start to finish. Capable of handling all aspects of validation work, including the creation of IQ, OQ, and PQ documents.

• Degree level in Science/Engineering field.
• Minimum 3+ years of experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
• Experience in aspects of Validation and ISO 13485 with proven knowledge of FDA and MDD GMP requirements regarding medical devices or pharma.
• Must be able to speak, comprehend, and write English. level (reading and writing) with basic conversation skills.

• GD&T and Statistical Engineering Qualification.

Associate

Contract

Engineering, Manufacturing, and Consulting

Manufacturing, Engineering Services, and Medical Equipment Manufacturing