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