Validation Engineer
Astrix Technology
Validation Engineer
Engineering
Anaheim, CA, US
+ Added - 05/11/2024
Apply for Job
Performs diverse tasks focused on equipment and facility change controls, training, and validation (IQ/OQ/PQ/PV) to maintain compliance with GMP standards and customer requirements. Ensures that validation protocols and reports are executed promptly, keeping manufacturing equipment and facilities in a validated state.
**Pay:** $69-$80k/yr, depending on experience
**Key Responsibilities:**
+ Lead validation programs covering equipment, processes, cleaning, and facility requirements.
+ Develop and update internal procedures to meet regulatory and quality standards.
+ Ensure thorough documentation and completion of recording forms, inspections, and procedures.
+ Work cross-functionally to facilitate accurate execution of validation activities.
+ Track and analyze data to ensure process consistency and reliability.
+ Document protocols and diagrams using electronic tools like Visio and MS Office.
+ Promote a collaborative team environment, encouraging respect, continuous improvement, and high performance.
+ Maintain compliance with company policies, safety protocols, and GMP standards, prioritizing health and safety in all activities.
**Qualifications:**
+ Bachelor’s degree in engineering or equivalent experience.
+ Minimum of 5 years in an FDA-regulated industry, including 3+ years in direct validation.
+ Strong data analysis, problem-solving, and critical-thinking abilities.
+ Knowledgeable in GMP and regulatory guidelines for personal care and OTC products.
+ Skilled in cross-functional teamwork with manufacturing, QA, supply chain, and compliance teams.
+ English fluency; bilingual in technical Spanish preferred.
+ Onsite work required.
INDBH #LI-DNP
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Confirm your E-mail: Send Email
All Jobs from Astrix Technology