| Equipment Validation Engineer | Houston, TX Onsite at Houston, Texas, USA |
| Email: [email protected] |
| Hi All, Pls share resume for this role. Title: Equipment Validation Engineer Location: Houston, TX Onsite Duration: 6+ months Type:- Contract ***The ideal candidate will possess a minimum of 5 years of experience in the pharmaceutical or medical device industry, with autoclave (sterilizer), Purified water System, Pure Steam validation. This role is essential in ensuring the effective and compliant operation the equipment, contributing to the overall quality and safety of our products.*** Must have Qualifications: Experience with statistical process control (SPC) and data analysis. Knowledge of steam sterilization equipment and purified water system. Responsibilities: Develop, execute, and review comprehensive validation protocols for autoclaves and sterilizers, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Conduct thorough risk assessments to identify potential equipment and process-related risks and implement effective mitigation strategies. Collaborate with cross-functional teams, including engineering, production, and quality assurance, to ensure seamless validation execution and compliance. Author and maintain detailed validation documentation, including protocols, reports, and deviations. Investigate and resolve validation-related deviations and out-of-specification results, implementing corrective and preventive actions (CAPAs) as needed. Stay up-to-date with industry regulations and standards (e.g., FDA, EMA,GMP, ISO) to ensure compliance. Provide technical expertise and support for autoclave/sterilizer-related inquiries and investigations. Participate in continuous improvement initiatives to enhance validation processes and efficiency. Qualifications: Bachelor's degree in Engineering, Science, or a related field. Minimum of 5 years of experience in autoclave/sterilizer validation within the pharmaceutical or medical device industry. In-depth knowledge (SME Level) of autoclave/sterilizer principles, operation, and maintenance. Experience with Control Systems (PLC, HMI, SCADA). Experience in Computer System Validation. Experienced in Qualifying Purified water system, and Pure Steam Generators. Experience using Temperature Dataloggers like Kaye AVS, Ellab EValPro. Strong understanding of validation methodologies and regulatory requirements (FDA, EMA, GMP, ISO). www.ehub.global Om Keshari Technical Recruiter Ehub Global M: 214-396-3315 [email protected] 450 Century Parkway, Suite 250, office 230 Allen, Texas,75013 Stay green - don't print this e-mail! USA | COSTA RICA | CANADA | INDIA Ehub Global provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. We especially invite women, minorities, veterans, and individuals with disabilities to apply. EEO/AA/M/F/Vet/Disability. -- Google Groups "Urgentinterviewc2crequirements" . Keywords: Texas Equipment Validation Engineer | Houston, TX Onsite [email protected] |
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| Thu Aug 22 00:25:00 UTC 2024 |