Validation Engineer
BEPC Inc. - Business Excellence Professional Consulting
Goodfellow Air Force Base, TX (In Person)
Full-Time
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Job Description
Type:
full-timeJob Description:
BEPC Inc . is seeking a detail-oriented Medical Validation Engineer to support our client in ensuring manufacturing processes and equipment meet regulatory and quality standards. This role is ideal for an early-career professional with hands-on validation experience in regulated environments such as medical devices or pharmaceuticals. You will collaborate with cross-functional teams to validate processes, troubleshoot issues, and ensure compliance with industry standards including FDA and ISO requirements. Key Responsibilities Develop and execute validation protocols including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for manufacturing and laboratory equipment. Generate equipment and fixture matrices aligned with Minimum Viable Product (MVP) requirements. Author validation protocols and comprehensive validation reports upon completion. Support development and implementation of Standard Operating Procedures (SOPs) for validated processes and equipment. Perform troubleshooting, root cause analysis, and implement corrective actions in compliance with GMP standards. Manage multiple validation projects simultaneously, ensuring timelines and quality standards are met. Collaborate with cross-functional teams to ensure product safety, reliability, and performance. Maintain accurate and detailed technical documentation in line with regulatory expectations. Qualifications Bachelor's degree in Engineering, Life Sciences, or a related field. 1-2 years of experience in validation within medical device, pharmaceutical, or other regulated industries. Hands-on experience withIQ/OQ/PQ
validations and validation documentation. Working knowledge ofISO 13485, FDA
regulations, and GMP requirements . Strong analytical, problem-solving, and technical writing skills. Ability to manage multiple projects and adapt in a fast-paced environment. Effective communication skills with proficiency in English (written and verbal). AboutBEPC 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. ! If you're ready to advance your career in validation engineering, we encourage you to apply. Please submit an up-to-date resume highlighting specific examples of your validation experience, includingIQ/OQ/PQ
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