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Validation manager • 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
R&D Partners is seeking to hire a.Your main responsibilities as a.Quality Specialist - Validation.Assists in the development of cGMP operating procedures that relate to process, computer systems, a...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
We are seeking a highly motivated and scientifically rigorous Scientist.Bioscience Process and Validation.This role operates at the critical intersection of engineering innovation and animal welfar...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
We think shopping should be fun.As in scoring our exclusive collection of colorful, classic styles at prices that can't be beat.
A fan of lots of options in amazing fits? You've got it.Looking for s...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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
We are seeking a highly motivated and scientifically rigorous Scientistto join ourBioscience Process and Validationteam.This role operates at the critical intersection of engineering innovation and...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Our Product Management team is actively seeking a Product Manager for Comply to join our passionate, driven and fast-paced team.
In this role, you will work with engineering, product, sales, marketi...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Essential Duties and Responsibilities.Other duties may also be assigned.First respondent to client requests.Evaluates crew leader performance.
Coordinates and communicates concerns between office an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_hours
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
Senior Manager / Manager, Customer Support.Join our mission to provide governments with exceptional experiences so they can do the same for their communities!.
We empower governments to deliver except...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
The Restaurant General Manager will be able to execute all restaurant administrative duties.You must be able to provide the leadership necessary to ensure the restaurant can sustain an acceptable l...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
We are looking for a Restaurant Manager to help manage our Dunkin' Team!.A Restaurant Manager is responsible for providing strong, positive leadership to his / her team to deliver great and friendly ...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
The Validation Engineer II assists with the authoring executing and reviewing of SOPs commissioning documentation documents required for validation / qualification.
Please note this role is on-site 5 ...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
IT-based systems across our facilities.This role is both strategic and hands-on, focusing on transforming, executing, and sustaining a risk-based Global Validation program to ensure compliance with...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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
Powering Performance Marketplaces in Digital Media.QuinStreet is a pioneer in powering decentralized online marketplaces that match searchers and "research and compare" consumers with brands.We run...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and pro...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_1_day
The Administrative Manager of Academic Resources and Operations provides comprehensive oversight of the department's academic and research resources while supporting broader operational planning an...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
Validation Engineer
Katalyst HealthCares & Life SciencesDurham, NCserp_jobs.job_card.full_time
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ADMINISTRATIVE MANAGER
Duke UniversityDurham, NC, USserp_jobs.job_card.full_time
Validation Engineer
Katalyst HealthCares & Life SciencesDurham, NCjob_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
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.
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Requirements :