Validation Engineer

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

W2 Contract - 5 months with possible extensions!

Benefits include medical, dental, vision, and life insurance

Compensation: $49.00 - $52.00/hour – Determined based on experience

Work Arrangement: 100% On-site

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

BEPC is seeking a highly skilled and detail-oriented Validation Engineer to support medical device and/or pharmaceutical manufacturing and laboratory operations. In this role, you will be responsible for ensuring that equipment, processes, and systems meet regulatory requirements and industry standards through the execution of IQ, OQ, and PQ validations.

The ideal candidate has a strong background in validation within regulated environments, a solid understanding of GMP and ISO 13485 requirements, and the ability to manage multiple complex validation projects from start to finish.

Summary of Duties and Responsibilities:

• Develop equipment and fixture matrices for MVP with defined qualification requirements
• Create detailed IQ/OQ validation protocols for medical device manufacturing and laboratory environments
• Execute technical IQ/OQ validation protocols in compliance with client standards and regulatory requirements
• Author validation completion reports following successful IQ/OQ execution
• Execute and complete PQ validations and author corresponding validation reports
• Provide technical expertise to develop and implement SOPs for newly validated equipment and processes
• Troubleshoot validation issues using root cause analysis and implement effective corrective actions
• Ensure compliance with GMP and applicable medical device regulations
• Manage multiple validation projects simultaneously from initiation through completion
• Independently handle all aspects of validation documentation (IQ, OQ, PQ).

Qualifications:

• Bachelor’s degree in Science, Engineering, or a related technical field
• Minimum 3 years of experience as a Validation Engineer in a medical device, pharmaceutical, or similarly regulated industry
• Strong working knowledge of validation processes and ISO 13485
• Proven understanding of FDA and MDD GMP requirements
• Ability to read, write, and communicate effectively in English.
• Strong attention to detail and analytical problem-solving skills
• Excellent technical writing and documentation capabilities
• Ability to manage complex projects and competing priorities
• Collaborative mindset with strong cross-functional communication skills
• Comfortable working independently in a regulated environment

Preferred Qualifications:

• Experience with J&J validation methodology
• Knowledge of GD&T and Statistical Engineering Qualification
• Experience with change documentation management systems such as Adaptiv
• Six Sigma Green Belt or Black Belt certification.

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!