Sr. Validation Engineer

BEPC is looking for a Sr. Validation Engineer in Fremont, CA to join our fast-growing team of consultants!

W2 Contract: 6 months with opportunities for extensions based on business needs and performance.

Pay Range: $60-75/hr., based on experience, plus we offer Medical, Dental, Vision and Life Insurance benefits!

Schedule: 100% Onsite

Note: This is a W2 only role

**Must be local to the Fremont area**

Our company is seeking a skilled Senior Validation Engineer to ensure that products and manufacturing processes meet regulatory requirements and industry standards, with a focus on New Product Introduction (NPI). The ideal candidate will have a strong understanding of validation principles, quality control, risk management, and regulatory guidelines. You will work closely with cross-functional teams in the development and launch of new medical devices, ensuring they meet safety, reliability, and performance standards. This role requires a detail-oriented, analytical mindset with experience in technical documentation and validation protocols.

Position Duties & 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.

Education & Experience Requirements

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.

Desirable Skills & 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.

USOPS