Jobs in the United States

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Added 1 min ago
MS
Vice President - Java Lead for Investment Banking Advisory Technology
MS Services Group, Inc.
NY
- $155,000 to $215,000 USD / year
…sizeable investment in technology results in quantitative trading systems, cutting-edge modeling and simulation software, comprehensive risk and security systems, and robust…
Added 1 min ago
MS
Lead Site Reliability Engineer
MS Services Group, Inc.
United States
- $155,000 to $215,000 USD / year
Support blockchain-connected infrastructure, node operations, digital wallet security systems, or distributed ledger technology (DLT) pipelines within a regulated framework.
Added 1 min ago
Graduate Electrical Engineer
Worley
Baton Rouge, LA · Baton Rouge
Exposure to industry tools, systems, or software relevant to your discipline (e.g., design, analysis, project controls, data, or planning tools).
Added 2 mins ago
Technical Specialist 1
GAI Consultants Inc
Louisville, KY
…environmental expertise to deliver projects across transportation, infrastructure, power, and energy markets. Working alongside accomplished colleagues, you’ll help move projects from…
Added 2 mins ago
Cloud Services Devops Engineer
Gordon Food Service, Inc.
Atlanta, GA
Build & Automate Cloud Systems: Use Infrastructure as Code (IaC) tools to provision, manage, and scale performant cloud environments.
Added 2 mins ago
Senior Network Security Engineer
Gordon Food Service, Inc.
Atlanta, GA
The Senior Network Security Engineer responsible for the design, architecture, implementation, and continuous improvement of the organization's network security strategy across hybrid,…
Added 2 mins ago
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Senior Warehouse Automation & Systems Engineer
AKIRA
Bolingbrook
- $100,000 to $120,000 USD / year
The Position: Senior Warehouse Automation & Systems Engineer
Added 5 mins ago
Electrical Engineer - Building Systems
Farnsworth Group
Phoenix, AZ
Farnsworth Group is seeking an Electrical Engineer - Building Systems to independently design and coordinate electrical systems for a broad range of commercial, industrial, institutional,…
Added 5 mins ago
Production Planning Engineer IV
Axiom Space
United States
Axiom Space is a human space exploration company, building era-defining space infrastructure and delivering technology-driven solutions that will empower civilization to transcend Earth.…
Added 6 mins ago
VoIP Engineer
TekSynap
Washington, DC
We are seeking a VoIP Engineer with an active Secret clearance for a full-time position as part of an ongoing contract in Washington, DC. The selected candidate will design, implement,…
Added 6 mins ago
Field Sales Engineer
MACOM Technology Solutions Holdings, Inc.
Lowell, MA
…semiconductor components, is seeking an experienced FSE (Field Sales Engineer) or Sr. FSE to drive sales in NC, VA, WV, DC and MD area. The FSE/ Sr. FSE will be focused on driving MACOM’s…
Added 9 mins ago
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Gas to Power Engineering Design Manager
AECOM
Houston, TX
- $190,000 to $240,000 USD / year
…projects involving gas to power generation, battery energy storage systems (BESS), electrical distribution and other associated site industrial infrastructure in support of…
Added 11 mins ago
Data Engineer (BigQuery)
Northramp LLC
Washington, DC · Reston, VA · Bethesda, MD
Northramp is seeking a Data Engineer (BigQuery) to join the team supporting a mission-critical effort to consolidate, modernize, and operate our client's enterprise cloud services across…
Added 13 mins ago
Asset & Wealth Management - Software Engineering - Vice President - New York
Campus
NY
…engineering teams that build massively scalable software and systems, architect low latency infrastructure solutions, proactively guard against cyber threats, and leverage machine learning…
Added 13 mins ago
Senior Full Stack AI Engineer (US Citizen)
Remote, United States
Serve as a senior, hands-on full-stack AI engineer, leading the design, development, and delivery of large-scale mission-critical AI systems.
Added 13 mins ago
Senior AI Software Developer & Engineer (US Citizen)
Remote, United States
Serve as a senior, hands-on full-stack AI engineer and technical authority, leading the technical strategy, design, and delivery of large-scale mission-critical AI systems supporting…
Added 14 mins ago
Senior Infrastructure Engineer, AI & ML, Penguin Random House (Open to Remote)
Apply now!
NY
…deliver models to production quickly. We are hiring a Senior Infrastructure Engineer to build and maintain the foundational systems that support this…
Added 14 mins ago
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Staff DevOps Engineer
ProphetX
Remote, United States
- $180,000 to $220,000 USD / year
We’re looking for a Staff DevOps Engineer to own the infrastructure, delivery pipelines, and reliability tooling behind our exchange and trading platform. You’ll build and run the cloud…
Added 15 mins ago
Senior Embedded Software Engineer
Intuitive
Sunnyvale, CA
Our team designs and builds the embedded platform software infrastructure that supports critical
Added 15 mins ago
Graduate Engineer, Water Resources
WESTWOOD PROFESSIONAL SERVICES INC
Houston, TX
In this role, you are expected to work on a team providing support to a licensed Civil Engineer while learning the company’s standard practices and local agency codes. As part of our Public…
Added 15 mins ago
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AWS Databricks Engineer
Credence
McLean, VA
- $155,000 to $185,000 USD / year
Credence has an immediate need for an AWS Databricks Engineer to join our growing AI and Automation practice. You will serve as a key technical contributor responsible for designing,…
Added 16 mins ago
Infrastructure Solution Engineer - ServiceNow development Experience
Syncreon Consulting
Pittsburgh, PA
Experience implementing systems using the Agile/Scrum (ITBM) methodology
Added 16 mins ago
Staff Developer Experience Engineer
Vetcove
Remote, United States
Vetcove is seeking a Staff Engineer to help us build 10x faster. AI is changing how software gets built, and we want someone who sees the opportunity and can make it real across Vetcove.…
Added 16 mins ago
Senior Director, Decision Intelligence & Data Products
Caliber Holdings LLC
Lewisville, TX
Data Architecture & Modernization: Drive modernization of legacy systems into a cloud-native, governed, and high-performance environment that supports AI and analytics at scale.
Added 17 mins ago
Senior Engineer, Unified Communications & Collaboration
ACE American Insurance Company
Jersey City, NJ · Philadelphia, PA
We are seeking a Senior Engineer to join our Global Unified Communications and Collaboration (UCC) chapter, where you will help shape the platforms and integrations that power how Chubb’s…

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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