Validation Engineer

BEPC Inc. - Business Excellence Professional Consulting; Santa Clara (CA); On-site; USD 82,656 - 89,544; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Job summary

A consulting firm is seeking a Validation Engineer in Santa Clara, CA. This role requires 3+ years of experience in the medical device or pharmaceutical industry and expertise in validation protocols. The successful candidate will create detailed validation documentation, manage projects, and ensure compliance with relevant regulations. Offering a competitive pay rate of $60-$65 per hour, the position is a 6-month contract with possible extensions. Benefits include medical, dental, and vision insurance.

Qualifications

• 3+ years of experience as a Validation Engineer in a regulated industry.
• Experience with FDA and MDD GMP requirements related to Medical Devices.
• Must be able to read, comprehend, and write English.

Responsibilities

• Generate equipment and fixture matrices for MVP.
• Create detailed IQ/OQ validation protocols.
• Execute detailed IQ/OQ validation protocols.
• Author validation completion reports.
• Provide technical expertise to develop SOPs.

Skills

Validation

Root Cause Analysis

Technical Writing

Problem-solving

Organizational Skills

Communication

Education

Bachelor’s degree in Science or Engineering

Tools

ISO 13485

Adaptiv

Job description

BEPC Inc. - Business Excellence Professional Consulting provided pay range

This range is provided by BEPC Inc. - Business Excellence Professional Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $65.00/hr

Direct message the job poster from BEPC Inc. - Business Excellence Professional Consulting

BEPC has an open position for a Validation Engineer

Benefits: Medical, Dental, Vision, and Life Insurance

Pay Rate: $60-$65 per hour (Paid Weekly)

Term: 6-months contract with possible extensions

Requirements: 3+ years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry.

Experience with Validation and ISO 13485, with demonstrated knowledge of FDA and MDD GMP requirements related to Medical Devices or Pharm.

**BEPC does not accept C2C, C2H, or W2 referral applications. **

Job Description

Position Duties & Responsibilities

• Generate equipment and fixture matrices for MVP, including qualification requirements as defined by the medical device company.
• Create detailed IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
• Execute detailed and technical IQ/OQ validation protocols aligned with client requirements and applicable standards.
• Author validation completion reports upon successful IQ/OQ completion.
• Execute detailed and technical PQ validations per client requirements and standards.
• Author PQ validation completion reports upon successful completion.
• Provide technical expertise to develop and implement Standard Operating Procedures (SOPs) for newly validated processes and laboratory equipment.
• Troubleshoot issues using root cause analysis, structured problem-solving, and implement effective corrective actions (CAPA) while following GMP requirements.
• Ensure compliance with relevant medical device/pharma regulations and quality systems.
• Manage multiple complex validation projects simultaneously from initiation through completion.
• Independently handle all aspects of validation documentation and execution, including development of IQ, OQ, and PQ documentation.

Education & Experience Requirements

• Bachelor’s degree (or higher) in a Science or Engineering discipline.
• 3+ years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry.
• Experience with Validation and ISO 13485, with demonstrated knowledge of FDA and MDD GMP requirements related to Medical Devices or Pharma.
• Must be able to speak, read, comprehend, and write English.

Desirable Qualifications

• Familiarity with J&J validation methodology.
• Knowledge of GD&T and Statistical Engineering Qualification.
• Experience with change documentation management using Adaptiv.
• Six Sigma Green Belt or Black Belt training/certification.
• Validation lifecycle expertise (IQ/OQ/PQ) and strong technical writing
• GMP mindset with compliance-focused execution
• Problem-solving, troubleshooting, and root cause analysis
• Strong organizational skills and ability to manage multiple projects
• Cross-functional collaboration and clear communication

About BEPC

BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees’ personal and professional growth.

Apply Now!

Qualified candidates are encouraged to apply by submitting an up‑to‑date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you!

Seniority level

Associate

Employment type

Contract

Job function

Manufacturing and Consulting

Industries

Manufacturing and Business Consulting and Services