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Validation Engineer

Company: Closure Systems International
Location: Kilgore
Posted on: May 12, 2022

Job Description:

Closure Systems International Inc (CSI) is a global leader in designing and manufacturing innovative closures for a wide range of applications in consumer and industrial markets. In addition to high quality closures and capping equipment, CSI provides unparalleled customer and technical services for high-speed application systems. Major categories served include carbonated soft drinks, bottled water, juices, isotonics, teas, adult beverages, dairy, foods, pharmaceutical and automotive fluids. CSI's cutting-edge closure solutions help customers maximize profits by increasing the marketability of their brands and optimizing their total cost of operations. From reducing the impact of manufacturing operations to an industry-leading suite of sustainable closure profiles, CSI---s sustainability expertise and sustainable product offerings ensure customers stay on top of market trends and consumer demands. CSI is headquartered in Indianapolis, IN, and produces 50 billion closures annually across its 9 manufacturing sites. We are currently searching for an experienced Validation Engineer to support our growing medical device business in Kilgore, Texas. Responsibilities Validate and implement medical device manufacturing processes as assigned. Support and provide validation oversight for capital expansion projects/build outs including packaging equipment and semi-automated and automated inspection systems Author validation documentation and protocols (IOQ, PQ, CCOQ, component assessments) as well as document template, validation strategies, policies, master batch records, component assessments, validation project plans, engineering protocols (commissioning, FAT, SAT). Conduct validation qualifications in accordance with all applicable protocols and identify associated exceptions. Review facility changes and provide input on re-validation and re-qualification of equipment Assess risks using FMEA or other risk analysis tools involved in processing steps related to equipment, developing and/or reviewing validation requirements and design deliverables. Develops statistically sound sampling plans and incorporates statistical analysis on results to reach data driven conclusions. Be a part of a cross functional team and work closely with other supporting groups including Global Engineering, Manufacturing Technology, Quality, and Operations to support and monitor validation and process improvement efforts Identify equipment/fixture installation qualification requirements and characterization of processes and their outputs/acceptance criteria. Written preparation of applicable validation reports that meet regulatory/company standards. Orchestrates validation activities. Develops protocols for testing equipment. Executes test plans, and documents results in validation reports Documenting and Managing Change - Justifies changes, quality and regulatory information, and manufacturing readiness information. Executes changes through document control and the quality system to implement project outcomes. Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and CSI---s Quality Management System where applicable. Must strictly adhere to safety requirements. Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision. Qualifications Bachelor---s Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field. Minimum 3 years--- experience in medical device process development or process validation. Direct experience authoring/editing/executing validation documents for equipment/facilities/utilities including FAT, IQ, OQ, PQ and change controls Good knowledge of FDA regulations, and ISO 13485 standards including Good Documentation Practice (GDP) Lean Six Sigma and Project Management experience Proficient in MS Office applications, Statistical and quality management software---s.

Keywords: Closure Systems International, Longview , Validation Engineer, Engineering , Kilgore, Texas

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