BEPC Inc. - Business Excellence Professional Consulting · 22 hours ago
Validation Engineer
Irvine, CA
Contract
Onsite
Mid Level
$59/hr - $63/hr
3+ years expBEPC Inc. is seeking a highly skilled and detail-oriented Validation Engineer to support medical device and/or pharmaceutical manufacturing and laboratory operations. The role involves ensuring that equipment, processes, and systems meet regulatory requirements and industry standards through the execution of IQ, OQ, and PQ validations.
BiotechnologyConsulting
Hiring Manager
Paola Borrero
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)
Qualification
Required
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
Preferred
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
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
201-500 employees
H1B Sponsorship
BEPC Inc. - Business Excellence Professional Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Oscar Casillas
President and CEO
Andrew Casillas
Human Resources Partner
Company data provided by crunchbase