Jobs in the United States

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Added 1 min ago
Senior Engineer
Motional
Remote, United States
Develop and execute comprehensive integration test plans for new vehicle features and subsystems, coordinating efforts across multiple engineering disciplines and external partners.
Added 2 mins ago
Manufacturing Engineer (Aerospace)
TAT Technologies Ltd
Tulsa, OK
We are seeking a Manufacturing Engineer to support our Tulsa Site by providing technical engineering expertise across MRO and OEM operations. The ideal candidate is a hands-on problem…
Added 6 mins ago
EC
Test Engineer
Eaton Corporation
Raleigh, NC
- $71,000 to $105,000 USD / year
This individual will be responsible for supporting design testing, lab setup, and design validation for a wide range of energy storage power conversion and UPS products. This individual…
Added 7 mins ago
Data Engineer
Electrosoft
Gaithersburg, MD
Data Engineer – Scientific Document and Data Pipelines
Added 11 mins ago
AI Enablement Engineer
FreedomPay
Philadelphia, PA
…across the globe in retail, hospitality, lodging, gaming, sports and entertainment, foodservice, education, healthcare and financial services. FreedomPay’s technology has been purposely…
Added 11 mins ago
Senior IT Engineer
Action1
Remote, United States
We are hiring a Senior IT Engineer to strengthen our corporate IT systems and security. You will work directly with the Head of IT, share daily operations with our EU-based Systems…
Added 13 mins ago
C
Senior Embedded Software Engineer
Capgemini
Santa Clara, CA, CA
- $89,400 to $166,398 USD / year
We are seeking a highly skilled and motivated Senior Embedded Engineer - RTOS Based Automotive Platforms to drive the software development, validation, and bring-up activities for…
Added 15 mins ago
TI
Systems Engineering Manager
TSI, Inc.
Shoreview, MN
- $160,000 to $180,000 USD / year
As both a people and technical leader, this role is responsible for hiring, coaching, and retaining top systems engineering talent and for building the capability needed to scale the…
Added 20 mins ago
Senior Engineer, Corporate Systems & Finance Technology
at Marriott
Bethesda, MD
The Application Solution Engineer for Oracle Enterprise Performance Management (EPM) is a subject-matter expert responsible for the design, implementation, and optimization of the full EPM…
Added 20 mins ago
Leo Cancer Care: Quality Engineer Level III
Centaur Health Holdings
Middleton, WI
The Quality Engineer is responsible for ensuring that Leo Cancer Care's products, processes and quality management systems consistently meet applicable regulatory requirements, recognized…
Added 20 mins ago
Quality Engineer
Transcendia, INC.
Hebron, OH
As a Quality Engineer at Transcendia, you will serve as a key change agent supporting manufacturing operations across our manufacturing campus that incorporates three buildings. This is a…
Added 23 mins ago
Software Engineer (Palantir Foundry / Microsoft Power Platform) - Clearance Required
LMI
United States
LMI is seeking a Software Engineer to build and deploy Army applications that connect Palantir Foundry data and services with Microsoft Power Platform workflows and user interfaces. This…
Added 25 mins ago
Sr Staff Engineer - Verification, CI/CD Infrastructure & Embedded Hardware (AISW)
Qualcomm Canada ULC
ON, CA
The Sr Staff Engineer Engineer, Verification (CI/CD & Embedded HW) is a senior individual contributor responsible for designing, scaling, and hardening CI/CD infrastructure and verification…
Added 26 mins ago
Senior Mechanical Engineer
SAIC
Lakehurst, NJ
Execute testing, validation, and troubleshooting procedures at various sites, including test locations, manufacturing facilities, and naval vessels
Added 29 mins ago
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Systems Engineer
Actalent
Springfield, VA
- $100,000 to $130,000 USD / year
Work EnvironmentThis is an onsite role based at a facility in Albuquerque, NM, with work performed on site five days per week
Added 29 mins ago
A
Systems Engineer (Cameo)
Actalent
Grand Rapids, MI
- $45 to $80 USD / hour
Job Title: Systems Engineer (Cameo)Job DescriptionWe are seeking a detail-oriented Systems Engineer to support a cleared program, focusing on requirements management, traceability, and…
Added 36 mins ago
Senior Systems Engineer
Dynetics, Inc
Huntsville, AL
Leidos’ Defense Sesors is seeking a Senior Systems Engineer to join our team in Lawton Oklahoma and Huntsville Alabama developing state of the art Counter Unmanned Aircraft Systems (C-UAS)…
Added 39 mins ago
Software Engineer
Visionist, Inc.
Columbia, MD
Visionist has an exciting new, fully FUNDED opportunity for a Software Engineer on our largest PRIME contract. Our team of Analysts and Engineers is motivated by the direct impact on the…
Added 39 mins ago
Applied AI Engineer
Visionist, Inc.
Columbia, MD
Visionist has an exciting new, fully FUNDED opportunity for an Applied AI Engineer on our largest PRIME contract. Our team of Analysts and Engineers is motivated by the direct impact on the…
Added 39 mins ago
RU
Nuclear ISI/PSI Program Engineer
Randstad USA
Remote, United States
- $50 to $58.57 USD / hour
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to…
Added 50 mins ago
S
Senior Quality Assurance (QA) Engineer, Officer
SSB&T
Irvine, CA
- $75,000 to $123,750 USD / year
We are seeking a Senior Quality Assurance (QA) Engineer with 5+ years of experience in software quality assurance, preferably within financial services. This role requires strong…
Added 53 mins ago
Senior General/Interdisciplinary Engineer
Odyssey Systems Consulting Group, Ltd.
Hanscom AFB, MA
Odyssey has an exciting opportunity for a Senior General/Interdisciplinary Engineer providing support to the Air Force Life Cycle Management Center/PEO Electronic Systems Directorate…
Added 59 mins ago
Staff Compliance Engineer
FuelCell Energy
Danbury, CT
The Senior Product Compliance Engineer will help guide product development activities by ensuring applicable certification, safety, and regulatory requirements are appropriately integrated…
Added 1 hour ago
Engineer II, DEV
Medical Murray
N Barrington, IL
…technologies that improve patient care worldwide. As an R&D Engineer II, you will play a key role in designing and developing innovative medical devices while leading development projects…
Added 1 hour ago
Engineer, Senior DEV
Medical Murray
N Barrington, IL
Develop feasibility, reliability, verification, and validation test plans.

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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Jobs in the United States