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Network Engineer, Foundation & Support
Meta
Jefferson City, MO
Meta's Edge & Network Services (ENS) team is actively looking for a Network Engineer to help us tackle the unique set of challenges and opportunities we face, while contributing to our…
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Director - Customer Response Engineering
Trellix
Jefferson City, MO
…strategic customers across our endpoint, data security, email, and network products. The role also owns prevention: finding risk in customer environments before it becomes an…
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Infrastructure Product Manager / Technical Program Manager
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Dearborn, MI
Experience as a Release Train Engineer, Product Manager, Platform Engineer, DevOps Engineer, or in a similar role.
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Junior Field Service Engineer
Actalent
Grand Rapids, MI
- $63,000 to $75,000 USD / year
…custom machine manufacturer as an entry-level Field Service Engineer. Ideal candidates are those eager to transition into controls, software, mechanical, or electrical engineering position…
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Cybersecurity, Privacy and Forensics - Palo Alto Networks XSIAM Engineer
PwC
Detroit, MI
As a SecOps Engineer specializing in Palo Alto Networks XSIAM or Google technologies, you will play a pivotal role in identifying and analyzing potential threats to an organization's…
Added 1 min ago
Cloud Engineer
Maximus
Lansing, MI
Maximus is seeking a Cloud Engineer to support a defense client remotely.
Added 1 min ago
OT Security Platform Engineer – Dragos
Cognizant
Lansing, MI
We are seeking an experienced OT Security Platform Engineer / Technical Lead to own and operate the Dragos security monitoring platform across a global manufacturing environment. This is a…
Added 1 min ago
Production Tech I
Lovejoy Curtis LLC
Muskegon, MI
Stay connected by joining our network and we'll keep you informed about upcoming events and opportunities that match your interests.
Added 20 mins ago
AE
Electronic Engineer
Advanced Energy Industries, Inc
Fort Collins, CO
- $90,000 to $120,000 USD / year
Added 20 mins ago
Network Engineer - Sr. Staff
Lockheed Martin
Colorado Springs, CO
The Network Communications Engineer will design, configure, secure, monitor, and troubleshoot complex, high-performance communication networks supporting mission-critical systems.
Added 20 mins ago
Staff Full Stack Engineer (Infrastructure) - FT telework - EADGE-T
Lockheed Martin
Colorado Springs, CO
EADGE-T is seeking a full stack engineer to join the project team with a focus as an Infrastructure Systems Engineer. In this role, you will:
Added 20 mins ago
Global Head of Infrastructure & Cloud Operations
Janus Henderson Investors
Denver, CO
Own the AI & data platform run-state. Engineer and operate the services behind our Medallion architecture (Snowflake, Azure, DBT) so analytics and AI use-cases scale across the firm.
Added 20 mins ago
K
Nuclear Quality Engineer-Kiewit Nuclear Solutions-Multiple Locations
Kiewit
Denver, CO
- $112,000 to $117,000 USD / year
…culture is strong at Kiewit Nuclear Solutions. As a Quality Engineer, you will report directly to the Quality Manager, and will administer the Project Quality Plan. In this role, you will…
Added 37 mins ago
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Quality Engineer
GPAC
Mishawaka, IN
- $80,000 to $100,000 USD / year
gpac is partnered with a growing international pet food manufacturer seeking a Quality Engineer – Raw Materials to support raw material quality, supplier performance, and laboratory…
Added 37 mins ago
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Quality Engineer
GPAC
Mishawaka, IN
- $80,000 to $100,000 USD / year
gpac is partnered with a growing international pet food manufacturer seeking a Quality Engineer – Raw Materials to support raw material quality, supplier performance, and laboratory…
Added 1 hour ago
Software Engineer-Developer, Phantom Works Weapons (Associate or Experienced)
The Boeing Company
Saint Charles, MO
The Boeing Company is seeking an Application Software Engineer (Associate or Experienced) to join the Phantom Works Weapons team in St. Charles, MO (St. Louis Area). This team supports…
Added 1 hour ago
Senior Industrial Engineer, Physical Flows, L'Oreal Operations
L'OREAL USA S/D, INC.
Kent, OH
Job Title: Senior Industrial Engineer, Physical Flows Location: Streetsboro, Ohio Department: Physical Distribution SBO - NAFS **Reports To:**Director, Distribution Management / SBO Site…
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Cybersecurity Engineer (Evergreen)
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Bridge Engineer
HDR ENGINEERING INC
Cincinnati, OH
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Engineer/Technical Specialist (Mid – Sr.) | Generation Control Systems Engineering
American Electric Power
Columbus, OH
Engineer -- Responsible to the assigned supervisor for performing intermediate level engineering work activities and projects requiring the application of engineering knowledge in a safe,…
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Network Engineer IV - Headquarters Network
Edward Jones
Saint Louis, MO
We are seeking an experienced Engineer who can provide technical leadership, drive platform modernization efforts, and contribute to the stability, scalability, and automation of our…
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SkillBridge - Network / Principal Network Communications Engineer
Northrop Grumman
Ellsworth AFB, SD
Northrop Grumman Aeronautics Systems has opening for an Network and Principal Network Communications Engineer to join our team of qualified, diverse individuals within our Ground Systems…
Added 2 hours ago
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Maintenance Mechanic
Aerotek
Plymouth, MA
- $24 USD / hour
…assistance and career development pathways.Work EnvironmentWe engineer precision components that power the medical, aerospace, and electronics industries. As an employee-owned company,…
Added 2 hours ago
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Middleware Engineer – Software AG Stack
Computer Task Group, Inc
UNAVAILABLE
- $48 to $52 USD / hour
CTG is seeking to fill a Middleware Engineer – Software AG Stack position for our client.
Added 2 hours ago
Senior Associate, Electrical Engineer RF
L3Harris
Melbourne, FL
Job Description: L3Harris is seeking a Electrical Engineer with a focus on RF SATCOM System development for the Melbourne/Palm Bay, FL location. In this role you will be responsible for…

Validation & Engineering Group

Sr Quality Assurance (Validation) Engineer - FL, USA

Deerfield Beach, FL, United States

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Job details

Experience: · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance.
Posting language: English
Posted: Apr 16, 2021

Original job description

Company Description Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer Systems. The Engineer will contribute improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of Operations, Process Development, and IT. The engineer will approve validation, change control, investigation of events as well as provide Quality oversight and/or Quality approvals for GxP systems. The CSQA Engineer will provide oversight of SHL Pharma GxP related applications, and established Quality Operating procedures. In addition; will maintain a list of all computerized systems that are used in support of manufacturing operations, assure 21 CFR Part 11 pre- and post-assessments are performed on all systems and that computerized systems are released to production in accordance with local and global policies and procedures. The CSQA Engineer will review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies. In addition, will provide guidance to project teams on the deliverables required as part of the validation package. Assure that computerized systems are in the requalification program and are part of the program for security access roster review. · To Implement and maintain global and local procedures for computerized systems validation. · To drive standardization and continuous improvement activities across the global and local quality network · To provide QA oversight, review and approval of the activities related to the design, test, implementation, and maintenance of supported GxP systems.

· To help plan audit program and execute audits of:

Suppliers of computerized systems, components, and services
Computerized systems, projects and processes related to Computerized system.
Computerized systems at SHL’s partners (e.g. CMO Customers}, upon request · To monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure. · To Identify and communicate risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk. · To ensure deviations from established procedures are documented per procedures. · To ensure that all changes that potentially impact product quality are documented per procedure. · To ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Advises site management regarding Quality Assurance issues

Qualifications

· Bachelor’s degree in Computer Science / Computer or Biomedical Engineering · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance. · Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems. · Must have a strong knowledge and application of the CFR’s and cGMP’s. · Comprehensive knowledge of FDA, EMA, JP, ISO and other regulations and experience in US and international regulatory agency inspections. · Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility. · Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. · Excellent oral and written communication skills with strong technical writing experience required. · Experience in internal / external audits, identify findings, drive resolution and provide closure report. · Proficient skills in solving complex problems and ability to bring issues to resolution. · Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. · Must be able to successfully pass a pre-employment drug test and background check. Experience working globally with diverse teams and cultures

Additional Information All your information will be kept confidential according to EEO guidelines.

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