Validation Engineer
BEPC Incorporated - irving, TX
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BEPC has an open position for a Validation Engineer in Irving TX Contract W2 Period: 1 year contract with possibilities for extensions. Pay & Benefits: Open depending on experience + Medical, Dental, Vision and Life Insurance SECTION 1: JOB SUMMARY* to identify process improvement initiatives and develops proposals for problem solving, improvement or optimization. process improvement projects that have the objectives of developing more cost efficient and quality enhanced processes. machine and process standards and overall equipment efficiency. in the development of more effective operational control systems. data generated through studies using statistical analytical methods. for the development and/or revision of production standards and standard work documents. writes and executes engineering studies, design of experiments, and IQ/OQ/PQ protocols and reports. SECTION 2: DUTIES & RESPONSIBILITIES* general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position: on optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management. technical support to the production areas evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions. adapts, and modifies methods and standards to control all aspects of assigned projects or portions of major projects. phases of work with other departments within the company and with other Medical Device divisions. Investigation and writes NC reports following established timelines. and follows up on NC reports through the evaluation, review and approval processes to comply with the established timeline. and participates in Cross Functional Investigations (CFI) and maintain engineering and equipment procedures. Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations. processes and analyze current status and potential future states with improvements. Define and quantify improvements to further analyze the gains. Use tools from Lean and Six Sigma to create and execute CIP projects. in GMP audits regarding equipment recording and machine performance. communications and interfaces with end users, machine manufacturers and/or suppliers. in projects involving other departments and activities (CIM, QIP, CFM, etc.). develops and implements validation procedures. J&J Safety Requirements and ensure safe working conditions and practices in the department. and analyzes data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results. Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs). for communicating business related issues or opportunities to next management level. for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. other duties assigned as needed. SECTION 3: EXPERIENCE AND EDUCATION* degree in engineering discipline. years' experience in engineering in a medical device environment preferred. SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS* computer skills and use of software applications. Strong computer background (MS Office, MS Project PowerPoint, Word, Excel, Outlook etc.) in a manufacturing environment developing manufacturing standards. ability to anticipate and solve problems. to prioritize multiple commitments and technical problem-solving duties. or knowledge in short and long-term project management. computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.). technical support to the production areas evaluating process deficiencies, process changes, modifications and equipment failure. Defines, analyzes, reviews and evaluates problems for prompt solutions. Daya Gracia Technical Recruiter-Life Science Mobile/Text: 3242 Executive Dr. | San Angelo, Texas 76905 Email: dayanara.gracia@
Created: 2024-10-09