Job Description

BEPC is actively looking for a Senior Validation Engineer in Fremont, CA area!

W2 Contract - 6 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Work Arrangement : 100% On-site

Compensation: $70.00-$74.00/hour

Note : This is a W2 only role — C2C, C2H, and W2 referrals will not be considered

We are seeking a highly motivated Senior Validation Engineer to join our manufacturing team, with a strong focus on New Product Introduction (NPI). This role is instrumental in ensuring equipment, systems, and processes are validated to meet regulatory and industry standards across all phases of medical device development and launch.

The ideal candidate brings a proven track record of managing validation protocols, technical documentation, and risk management — all while contributing to cross-functional NPI efforts. This position is suited for someone who thrives in a fast-paced environment, is detail-oriented, and possesses excellent problem-solving skills.

Summary of Duties and Responsibilities:

• Collaborate in NPI processes: Work closely with engineering, R&D, and manufacturing teams during the New Product Introduction phase to validate equipment, processes, and systems for newly developed medical devices. •Validation of manufacturing equipment and fixtures: Generate detailed equipment and fixture matrices for MVP (Minimum Viable Product), ensuring qualification requirements are met in alignment with medical device company standards.
• Create and execute IQ/OQ validation protocols: Develop detailed Installation Qualification (IQ) and Operational Qualification (OQ) validation protocols for both medical device manufacturing and laboratory settings, ensuring alignment with regulatory and client specific requirements.
• Perform PQ validations: Conduct Performance Qualification (PQ) validation to ensure the equipment operates within specified limits, meeting all product performance and regulatory standards.
• Author validation completion reports: Upon successful completion of IQ/OQ and PQ validations, prepare comprehensive validation completion reports to demonstrate compliance and performance.
• Develop SOPs: Lead the development and implementation of associated Standard Operating Procedures (SOPs) for newly validated processes and laboratory equipment, ensuring adherence to quality and regulatory standards.
• Problem-solving & troubleshooting: Apply strong troubleshooting skills, root cause analysis, and corrective implementation to resolve validation and manufacturing issues, while maintaining GMP compliance.
• Project management: Manage multiple complex validation projects, particularly those associated with new products, from initiation to completion. Provide guidance and ensure the successful execution of NPI projects.
• Documentation management: Prepare and maintain accurate validation documentation, including IQ, OQ, and PQ protocols and reports, ensuring traceability and compliance with all regulatory requirements. Perform other duties as required.

Qualifications:

• Degree in a Science/Engineering field.
• 3+ years of experience as a Validation Engineer in the medical device, pharmaceutical, or similarly regulated industry.
• Proven experience in New Product Introduction (NPI) processes, particularly in the validation of equipment, processes, and systems for newly launched products.
• Experience with ISO 13485 and knowledge of FDA, MDD, and GMP requirements regarding medical devices and pharmaceuticals.
• Strong written and verbal communication skills in English.
• Candidates must reside locally, in Fremont, CA

Preferred Qualifications:

• Knowledge of GD&T (Geometric Dimensioning and Tolerancing) and Statistical Engineering qualifications.
• Experience in changing documentation management using tools like Adaptiv.
• Six Sigma Green/Black Belt training/certification.
• Experience with NPI-related cross-functional collaboration, including design transfer, process development, and product launch support

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