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Validation engineer • durham nc
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Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program.This position provide...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation & Engineering Group, Inc.V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the followin...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Responsibilities : Systems engineering for product development teams focused on research, design, integration, and evaluation of robotic platforms and sub-systems.
Kinematic analysis and development ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Supports manufacturing and packaging departments through capital projects and continuous improvement initiatives.Leads critical capital projects, supports new product launches, and represents the E...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
We are seeking a proactive and adaptable Scientist to join our Bioscience Process and Validation team.This role plays a pivotal part in the development and validation of innovative biodevice produc...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Essential Duties and Responsibilities : .Design, build, and maintain scalable ETL / ELT pipelines to process large datasets efficiently.
Leverage Python for scripting and orchestration tasks.Develop and...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
A company is looking for a CCNA Network Solutions Validation Engineer.Key Responsibilities Engage with customers and stakeholders for successful validation planning and execution Support custome...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Location : Durham NC or Merrimack NH.Top Required Skills : Swift / SwiftUI XCTest UIKit & Core Data DevOps (Azure) Candidates MUST be strong communicators (verbal and written) The Health Care.serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Validation / Process Engineer Date : XXX Site : Durham, NC FLSA Status (US Only) : Exempt / Non-Exempt Department : Manufacturing Reporting To : (Title) Position Summary Medpharm seeks a talented Vali...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
More Than A Career - A Chance To Make A Difference In Peoples Lives.Build an exciting, rewarding career with us help us make a difference for millions of people every day.Consider joining the Duke...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
We are looking for a skilled Building Engineer to perform technical and mechanical functions for the purpose of operating property plant and equipment to achieve maximum energy efficiency, cost eff...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Our client, a leading technology solutions provider, is seeking a CCNA Network Solutions Validation Engineer to join their team.
As a CCNA Network Solutions Validation Engineer, you will be part of ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
CQV PQ Lead - Pharmaceuticals - North Carolina - 12-Month Contract .Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV PQ Lead to join their expanding tea...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Piper Companies is seeking an experienced.Raleigh Durham, North Carolina area for a worldwide leader in technology.Responsibilities of the Firmware Engineer include : .
Design and develop secure firmw...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Top Secret Backend Software Engineer.General Atomics Integrated Intelligence Inc.GA-I3) develops cutting-edge software solutions that transform raw data into actionable intelligence.We specialize i...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Length of Contract : months with strong likelihood to extend additional months.Validates software for Laboratory and Manufacturing software and instruments.
Understands how aspects of data integrity,...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
For over 30 years, Beghou Consulting has been a trusted adviser to life science firms.We combine our strategic consulting services with proprietary technology to develop custom, data-driven solutio...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Medical Devices Manufacturing Company.This is for an initial duration of.Job Title : Electrical Engineer.Position Type : Hourly Contract Position (W2 only).
We are seeking an Electrical Engineer who w...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Location : Durham, NC (100% Onsite Only).Interview : The interview schedule will be a phone screen, then an on-site panel.
In this role, you will be responsible for supporting sterilization technology...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Validation Engineer
Katalyst HealthCares & Life SciencesDurham, NCjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionThis position interacts with multiple functional groups within manufacturing and sterilization networks. Supports product sterility assurance and compliance across multiple sites within the Life Sciences division. Serves as the quality representative to support multiple projects within the division. Schedules / coordinates / performs assigned projects, compiles test data, writes summary reports and final reports. Provides validation support including master validation planning, change controls, protocol development, review and approvals, IQ / OQ / PQ execution / support, assist with FMEAs and control plans, assist with documentation in electronic document management system. Lead and support activities related to product changes impacting sterilization equipment / processes and the associated laboratory / functional testing required as part of the validations. Facilitate / support investigations for product and process discrepancies and propose corrective actions to process deviations and customer complaints. Assist with the investigation of Corrective & Preventive Actions (CAPA), providing solutions where possible. Create or modify user documentations that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards. Ensures compliance to regulatory requirements related to product sterility assurance including annual product reviews, environmental controls, bioburden testing, dose audit maintenance and sterility testing. Serve as a resource for performing internal audits to ensure quality system compliance. Drive improvements to deliver on key quality goals and metrics. Able to react to change and perform other duties as assigned. Bachelor's Degree required, prefer program in Sciences or Engineering. Minimum of + years of quality engineering experience in a highly regulated industry; strongly prefer medical device or pharmaceutical. Direct experience in sterility assurance or product sterilization a plus. Strong knowledge of the regulatory and quality system requirements CFR Parts , / , ISO , ISO , ISO and ISO . Leadership ability to coordinate projects at multiple locations in a multi-functional team environment. Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication. Knowledge of manufacturing processes and relevant statistical methods for quality assurance. Good understanding of continuous improvement methodologies, including lean, six sigma, statistical applications and validation. Must have proficiency using Microsoft Office, Project, Outlook, and software applications. Demonstrated technical writing skills. Experience with sterilization processes highly preferred. ASQ Certified Quality Engineer desired. Minitab software proficiency, desired. Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams. Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish work being executed.
Job Description :
- Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program.
- This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.
- This position works closely with other functions within the organization (Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement and Marketing) and is responsible for ensuring the sterilization requirements are met for product sterilized to ensure compliance to regulatory, customer and internal standards.
Responsibilities :
Requirements :