Jobs in the United States

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Added 2 mins ago
A
Mid-Level Civil Construction Engineer (4 years experience required)
AECOM
Fresno, CA
- $80,000 to $140,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
A
Mid-Level Civil Construction Engineer (4 years experience required)
AECOM
Bakersfield, CA
- $80,000 to $140,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
A
Mid-Level Civil Construction Engineer (4 years experience required)
AECOM
Sacramento, CA
- $80,000 to $140,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
A
Railroad Bridge Engineer
AECOM
Sacramento, CA
- $140,000 to $240,000 USD / year
…resolves field engineering issues to ensure compliance with project specifications, design standards, and regulatory requirements. The Engineer serves as the primary technical liaison among…
Added 2 mins ago
A
Railroad Bridge Engineer
AECOM
Fresno, CA
- $140,000 to $240,000 USD / year
…resolves field engineering issues to ensure compliance with project specifications, design standards, and regulatory requirements. The Engineer serves as the primary technical liaison among…
Added 2 mins ago
A
Railroad Bridge Engineer
AECOM
Bakersfield, CA
- $140,000 to $240,000 USD / year
…resolves field engineering issues to ensure compliance with project specifications, design standards, and regulatory requirements. The Engineer serves as the primary technical liaison among…
Added 2 mins ago
A
Civil Construction Engineer (2 years of experience required)
AECOM
Bakersfield, CA
- $80,000 to $120,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
A
Civil Construction Engineer (2 years of experience required)
AECOM
Fresno, CA
- $80,000 to $120,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
A
Civil Construction Engineer (2 years of experience required)
AECOM
Sacramento, CA
- $80,000 to $120,000 USD / year
Perform quality assurance/quality control (QA/QC) checks on datasets and reporting outputs
Added 2 mins ago
Data Center Electrical Engineer
Google
Bridgeport, CT
As a Data Center Services Electrical Engineer, you will play a crucial role in the field-level implementation and operational support of Google’s rapidly expanding data centers. You will be…
Added 2 mins ago
Process Engineer Staff
Plexus Manufacturing Sdn. Bhd.
Neenah, WI
Purpose Statement: The process engineer is responsible for providing technical expertise throughout the manufacturing process. This role involves offering guidance on best practices and…
Added 6 mins ago
Advanced Lead Supplier Quality Engineer - Composites
GE Aerospace
Cheyenne, WY
The Supplier Quality Engineer for Polymer Matrix Composites is an individual who can apply knowledge of RCCA and/or problem solving to lead supplier quality improvement of complex cross…
Added 25 mins ago
Staff Quality Systems Engineer
J&J Family of Companies
Danvers, MA
We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment. This…
Added 26 mins ago
RA
Senior Program Manager & Key Client Lead, Data Centers
Ramboll Americas Engineering Solutions, Inc.
Boston, MA
- $150,000 to $225,000 USD / year
You will combine program and project management with technical and key-client leadership, with accountability for delivery performance, technical and commercial rigor, and account growth.…
Added 26 mins ago
Power System Controls Engineer – Data Centers
Jacobs
Boston, MA
Jacobs’ Energy & Power business is seeking a Power System Controls Engineer to support conceptual planning, design, modeling, integration, and validation of Data Center controls ecosystem…
Added 49 mins ago
Consultant, Black & Veatch Corporation, Phoenix, AZ Job Details | Black & Veatch Family of Companies
Black & Veatch
Phoenix, AZ
…technical memoranda, reports, and planning documents. Perform Quality Control review of the technical reports, field documentation, future planning recommendations. Collaborate with…
Added 1 hour ago
ER
Systems Architect - Manning - Information Systems Systems
El Rio Community Health Center
Tucson, AZ
- $47.06 to $77.6 USD / hour
…making. The SA will participate as part of a technical and/or project team to ensure projects are implemented according to architectural, technical, organizational, and budgetary plans. The…
Added 1 hour ago
Data Engineer
Deep Digital Solutions Group
United States
Job Description: Deep Digital are seeking a highly skilled and experienced Senior Data Engineer with a proven track record in successfully implementing, optimizing, and maintaining the data…
Added 1 hour ago
Engineering Manager
Kyoto Fusioneering America
Oak Ridge, TN
…functionally to the Head of Engineering and operates within a matrixed project structure, interfacing directly with the relevant technical area leads, project lead(s), and Project Director…
Added 1 hour ago
Associate Director, Power Systems Engineering
Scout Clean Energy
Boulder, CO
…specifications, governing electrical system design, supporting project execution, and ensuring operational readiness of Scout’s projects in Development and Construction. Your team will…
Added 1 hour ago
Senior/ Staff Software Engineer, Platforms
Sagora
Boston, MA
…into hours, continuously improving the performance, cost and quality of customers’ AI models, pipelines and…
Added 1 hour ago
SA
Electrical Engineer - Subsea Motion Control & Power Electronics
Straffing AI
San Diego, CA
- $125,000 to $150,000 USD / year
We are seeking an experienced Electrical Engineer to join an innovative engineering team developing advanced electromechanical systems for demanding subsea applications. This is an…
Added 1 hour ago
BE
Project Manager - Costa Mesa, California
Beyond Elevation Workforce Solutions
Costa Mesa, CA
- $100,000 to $125,000 USD / year
Ensure quality assurance/quality control (QA/QC) processes are followed, and manage project budgets effectively while establishing design criteria.
Added 1 hour ago
M
Senior Mechanical Engineer
Microsoft
NC · Charlotte, NC · Charlotte
- $119,800 to $261,000 USD / year
…that powers our cloud services. As a CO+I Senior Mechanical Engineer, you will perform a key role in delivering the core infrastructure and foundational technologies for Microsoft's online…
Added 1 hour ago
M
Energy Resource Manager
Microsoft
IL · Chicago, IL · Chicago
- $84,400 to $186,600 USD / year
…Electrical Engineers and Critical Environment Field Service…

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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