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Posted: Thursday, February 8, 2018 11:24 AM

Job Description
We are seeking a Senior Validation Engineer to join our team
The Senior Validation Engineer is responsible for all aspects Process Validation, Equipment Validation and Cleaning Validation used in the development and production of medical device / pharma products.
This is a hands:on position which to develop and execute validation life cycle activities according to necessary specifications and operating ranges to ensure the production of quality products.
This person will also take a leadership role in engineering functions such as specifying and validating new equipment, process and materials, technical services, identifying and implementing process/product improvements.
This person will support validation life cycle activities and lead process, equipment and cleaning validation projects.
ESSENTIAL FUNCTIONS AND BASIC DUTIES
:Conduct validation or qualification studies of new or existing processes, equipment, systems or software in accordance with internal protocols or external standards.
:Develop validation master plans, validation protocols, summary reports, deviations, process flow diagrams, test cases, and standard operating procedures/work instructions as applicable.
:Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, and other types of production.
:Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
:Perform DOEs and statistical analysis and support process improvements projects.
:Lead periodic review of equipment and critical utilities for the entire site.
:Lead cleaning validation annual monitoring projects.
:Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
:Develops manufacturing processes by designing and modifying equipment for fabricating, building, assembling, and installing components.
:Provide support to R and D, manufacturing, marketing, and customer service; interface with customers and suppliers
:Using six sigma principals, identify key process parameters and develop monitoring tools to enable cost reduction efforts
:Manage projects in a matrix organization as a team leader, whose duty encompasses the full scope of the project
:Drive capacity improvements by identifying and executing continuous improvement projects
:Mentor and coach team engineers in developing new products and technologies
:Support design and process FEMAs
:Author and execute validation protocols and summary reports for equipment qualifications, process and packaging validation, and cleaning validation processes to ensure regulatory agencies compliance.
:Lead technical training efforts to corporate and plant personnel regarding the fundamentals of validation and the use of Design of Experiment and Factory Acceptance Testing.
:Participate as Subject Matter Expert (SME) in the New Product Development Process.
:Support validation life cycle activities by commissioning, continuous process monitoring, change controls, SOP generation, and re:validation activities.
:Maintain Regulatory and Quality compliance, and follow PDI safety, health and environmental policies and procedures.
QUALIFICATIONS
EDUCATION/CERTIFICATION:
:Bachelors Degree in Engineering discipline. Pharmaceutical, Mechanical, Electrical, or Automation Engineering preferred.
:Candidates with M.S. or B.S. with significant additional relevant experience in manufacturing science and technology can be considered.
REQUIRED KNOWLEDGE:
:Thorough knowledge of FDA Guidance for Industry. Process Validation: General Principles and Practices
:Thorough knowledge of good manufacturing and documentation Practices.
:Knowledge of FDA regulatory guidance, ICH guidelines and 21 CFR Parts 210, 211, and 820.
:Thorough understanding of drug product
manufacturing/packagin

Source: https://www.tiptopjob.com/jobs/78078821_job.asp?source=backpage


• Location: Hudson Valley, orangeburg

• Post ID: 35911602 hudsonvalley
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