Validation Engineer (Medical Industry)

Description

• Provide technical expertise and support to develop and implement all associated Standard Operating Procedures for newly validated medical device processes and laboratory equipment.
• 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.
• Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
• 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.
• Change documentation management using Adaptiv.

Requirements

BEPC has a Santa Clara, CA. area OPEN POSITION for Validation Engineer to ensure that products and manufacturing processes meet regulatory requirements and industry standards. Have a strong understanding of quality control principles, risk management, and the ability to interpret and apply regulatory guidelines. Collaborate with cross-functional teams to address issues, troubleshoot problems, and ensure devices meet safety, reliability, and performance standards. Detail-oriented, analytical, and skilled in technical documentation and validation protocols.

• -This role is not offered on a C2C basis, and candidates under this arrangement will not be considered--
• Successful completion of PQ validations and author validation completion reports.
• Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
• J&J validation methodology.
• 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.
• Minimum 3+ years of experience as a Validation Engineer within a medical device, pharmaceutical, or similar regulated industry.
• Degree level in Science/Engineering field.
• Six Sigma Green/Black Belt trained/Certified
• GD&T and Statistical Engineering Qualification.
• Must be able to speak, comprehend, and write English. level (reading and writing) with basic conversation skills.
• Experience in aspects of Validation and ISO 13485 with proven knowledge of FDA and MDD GMP requirements regarding medical Devices or Pharma.

Benefits

Training + Development

Interview process

Visa Sponsorship

Security clearance