Jobs in the United States

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NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Suffern, NY
- $123,208 to $133,608 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
NY
Professional Engineer 1 (Civil/Transportation) multiple vacancies
New York State Civil Service
Cheektowaga, NY
- $94,716 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation) multiple vacancies
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Cheektowaga, NY
- $94,716 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Syracuse, NY
- $94,716 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Syracuse, NY
- $87,716 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Albany, NY
- $112,392 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Albany, NY
- $112,392 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
EG
Workday Adaptive Planning Engineer
Eliassen Group
Albany, NY
- $65 to $75 USD / hour
Our client is seeking a Workday Adaptive Planning Engineer to design, build, and maintain financial planning and forecasting solutions. The role partners with FP&A, Accounting, and Finance…
Added just now
NY
Professional Engineer 1 (Civil/Transportation)
New York State Civil Service
Albany, NY
- $112,392 to $130,208 USD / year
Title Professional Engineer 1 (Civil/Transportation)
Added just now
EG
Quality Assurance Engineer - PHP
Eliassen Group
Albany, NY
- $40 to $50 USD / hour
Our client seeks a results-driven Senior Quality Assurance Engineer to support Policyholder Portal applications. The role requires manual, automation, mobile, API, and database testing…
Added just now
Principal Mechanical Engineer
QinetiQ US
Devens, MA
QinetiQ US is seeking a highly motivated Principal Mechanical Engineer, who will be responsible for the design, development, analysis, and design maintenance of military and commercial…
Added 2 mins ago
WI
Staff, Software Engineer - FullStack Java Engineer
Walmart Inc.
United States
- $143,000 to $286,000 USD / year
The Staff Software Engineer will lead the design, development, and deployment of scalable platform capabilities, including infrastructure, tooling, and AI/ML frameworks. This role requires…
Added 3 mins ago
IT Project Lead
BAE Systems
Washington, DC
…recommendations for architecture design following IA accreditation…
Added 3 mins ago
Field Service Engineer
BAE Systems
Nashua, NH · Totowa, NJ
Identify recurring failure trends and recommend reliability and process improvements.
Added 3 mins ago
Senior DevSecOps Engineer
BAE Systems
Nashua, NH
…Architecture Team (DAT) is looking to hire a Senior DevOps / DevSecOps Engineer to join our team. We are responsible for transitioning Engineering and Operations from legacy software and…
Added 3 mins ago
Hardware Engineering Lead
BAE Systems
Wayne, NJ
BAE Systems is seeking a Lead Hardware Engineer to provide design expertise and leadership within our emerging and development programs. Our team creates innovative technologies and…
Added 3 mins ago
Compliance Support Engineer
Prelude
Remote, United States
…our sales team and our customers. You'll also help make the process faster and smarter as we…
Added 7 mins ago
A
Senior Transportation Manager
AECOM
Lisle, IL
- $165,000 to $200,000 USD / year
Professional Engineer (PE) license in Illinois, or the ability to obtain Illinois licensure through reciprocity within six months of hire.
Added 8 mins ago
Staff Platform Engineer
Jobgether
Remote, United States
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Staff Platform Engineer based in United States.
Added 8 mins ago
J
Staff Machine Learning Engineer - Team Lead (Active Secret Clearance)
Jobgether
Remote, United States
- $230,000 to $280,000 USD / year
…steps. Our partner is looking for a Staff Machine Learning Engineer - Team Lead (Active Secret Clearance) based in the United…
Added 8 mins ago
Staff Fullstack Engineer (TypeScript)
Jobgether
Remote, United States
…and next steps. Our partner is looking for a Staff Fullstack Engineer (TypeScript) based in the United…
Added 8 mins ago
Staff AI Engineer
Jobgether
Remote, United States
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Staff AI Engineer based in United States.
Added 8 mins ago
Senior Staff Software Engineer
Jobgether
Remote, United States
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Staff Software Engineer based in the United States.
Added 8 mins ago
J
Principal Engineer, Enterprise Scalability
Jobgether
Remote, United States
- $244,000 to $366,000 USD / year
…applications and next steps. Our partner is looking for a Principal Engineer, Enterprise Scalability based in the United States…
Added 8 mins ago
J
Engineering Manager, Software Engineering (Java Backend)
Jobgether
Remote, United States
- $120,000 to $170,000 USD / year
…Manager, Technical Lead, Engineering Lead, or Staff Software Engineer with team leadership…

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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