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BEPC Inc. - Business Excellence Professional Consulting provided pay range

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Base pay range

$60.00/hr - $75.00/hr

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Talent Acquisition Specialist II at BEPC Inc. - Business Excellence Professional Consulting

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. 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.
• Experience with NPI-related cross-functional collaboration, including design transfer, process development, and product launch support.

USOPS

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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