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Validation Engineer

Cyber Sphere LLC

Remote • Yesterday

Easy Apply

Third Party, Contract

Depends on Experience

Lead Infrastructure Engineer - Hybrid Cloud & Automation Solutions

EPAM Systems

Remote • Today

Full-time

Lead Infrastructure Engineer - Hybrid Cloud & Automation Solutions

EPAM Systems

Remote or New York, New York • Today

Full-time

Lead Data Engineer

UnivEdge Consulting LLC

Remote • 2d ago

Easy Apply

Full-time

Depends on Experience

Senior Cloud Infrastructure Engineer

Lumen Solutions Group Inc.

Remote • Yesterday

Easy Apply

Contract

Depends on Experience

Lead Snowflake Engineer- Remote #Vaiticka Solution

Vaiticka Solution LLC

Remote • 10d ago

Easy Apply

Contract, Third Party

$62 - $65

Lead Engineer Automation Quality

Empower Annuity Insurance Company of America

Remote or Overland Park, Kansas • 30+d ago

Full-time

USD 105,700.00 - 149,275.00 per year

Sr. Lead Engineer, Integration & Automation

ServiceTitan

Remote or Glendale, California • Today

Full-time

Compensation information provided in the description

Lead Validation Engineer

E Tech Group

Raleigh, North Carolina • Today

Full-time

Threat Modeling Automation Lead

Motion Recruitment Partners, LLC

Charlotte, North Carolina • Today

Easy Apply

Contract

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Senior Engineer - Industrial Automation

The Haskell Company

Charlotte, North Carolina • Today

Full-time

Lead Software Engineer

Bonterra

Remote • Today

Full-time

USD 130,000.00 - 145,000.00 per year

Lead Test Engineer (Oracle APEX applications) - US Cit / PR to pass security clearance

ec3 Federal Services

Remote • 3d ago

Easy Apply

Full-time

Depends on Experience

Specialized Application Consultant: IV (Lead)

Randstad Digital

Remote or Madison, New Jersey • Today

Contract

USD70 - USD80

Lead Python Test Automation Engineer

EPAM Systems

Remote • Today

Full-time

Senior Electrical Substation Design Project Engineering Manager 3

GE Vernova

Remote or Oak Brook, Illinois • Today

Full-time

USD 120,000.00 - 180,000.00 per year

Data Engineer IV

Dexian DISYS

Charlotte, North Carolina • Today

Easy Apply

Contract

$75 - $85 per hour

Telecom Analyst / Senior Power Engineer

Strategic Staffing Solutions

Raleigh, North Carolina • Today

Easy Apply

Contract

USD0 - USD0

Sr Integration Platform Engineer

STAND 8

Remote • Today

Easy Apply

Contract

$80 - $90 per hour

Sr MDE Development Support Engineer

NetVision Resources Inc

Remote or Hybrid in Woodlawn, Maryland • Today

Easy Apply

Full-time, Contract, Third Party

Observability Lead-Sr. Infrastructure Engineer-ON-SITE REQUIRED IN LISTED TRUIST HUBS

Truist

Charlotte, North Carolina • Today

Full-time

Service Automation Software Engineer

Viasat, Inc.

Remote or California • Today

Full-time

USD 165,000.00 - 260,500.00 per year

Senior Electrical Substation Design Project Engineering Manager 2

GE Vernova

Remote • Today

Full-time

USD 131,700.00 - 219,300.00 per year

Loftware Spectrum Technical Lead / Solution Engineer

NTT DATA Americas, Inc

Remote • 12d ago

Easy Apply

Contract

Depends on Experience

Enterprise Automation Architect –Stonebranch Migration

Turing IT Labs

Remote or Hybrid in Boston, Massachusetts • Yesterday

Easy Apply

Contract

Depends on Experience

Data Product Manager, Marketing Technology

ServiceNow, Inc.

Remote or Santa Clara, California • Today

Full-time

USD 116,400.00 - 192,100.00 per year

Lead Senior Technology and Data Engineer - Raleigh, Nc

Motion Recruitment Partners, LLC

Raleigh, North Carolina • Today

Easy Apply

Contract

$90 - $100

Cloudflare / Edge Security Engineer

SolutionIT, Inc.

Remote • Today

Easy Apply

Third Party, Contract

Pipeline Facilities Engineer

VDart, Inc.

Remote • 6d ago

Easy Apply

Contract, Third Party

Depends on Experience

Sr. Ethernet Network Engineer

INSPYR Solutions

Remote • 24d ago

Easy Apply

Contract

Depends on Experience

Job Details

Skills

Validation Engineer
21CFR820
21CFR Part 11
ISO 13485
Capability Maturity Model
CMM
good automation manufacturing practices
GAMP

Summary

Validation Engineer
Remote
Long Term
Contract

validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s

Health policies and procedures, and industry standards. This individual will assist the company to develop and implement operating procedures associated with individual projects designed to support quality system related validation protocols in a way that embraces 21CFR820, 21CFR Part 11 and ISO 13485

requirements.

Primary Responsibilities

Reviews site software/process applications and provide computerized system validation, consultation, training, and evaluation.
Lead and manage software and process validation projects by reviewing, assisting with the preparation of and, where appropriate, executing validation protocols, test plans and reports.
Creates regulation awareness and develops inherent validation requirements and protocols within their site that align with Client s Health policies and procedures.
Liaise with colleagues and site management associated with Manufacturing, IT/IS Systems, Software and Hardware design groups to create best validation practices within the business.
Coordinate, track and report on validation tasks.

Key/Critical Competencies

Strong Knowledge of US FDA and international validation requirements and associated regulations including 21 CFR Part 820, 21 CFR Part 11, ISO 13485, good automation manufacturing practices (GAMP), software life cycle development methodology, and Capability Maturity Model (CMM)
Ability to interface with developers and lead validation projects on one or more operating systems including but not limited to Lotus Notes, VAX/VMS, Visual Basic, Oracle, SAP, Sequel, MasterControl, and other similar enterprise-based systems.
Knowledge of network operating systems, medical device-based protocols and regulations impacting validation of medical information systems (e.g., HIPAA).
Working knowledge of validation practices to include Software, Products, Process, Facilities, Equipment, and Utilities, networks, servers and operating systems.
Demonstrates excellent written, oral and interpersonal skills with personnel at all levels
Exhibits a high degree of integrity, initiative and motivation.

Education and Experience

A BS degree or higher in Engineering, Computer Science or other commensurate technical degree with 3+ years of experience in computer validation in an FDA regulated industry.
Experience in medical device systems software and/or process validation.
FDA audit experience (preferred)

Munesh

CYBER SPHERE LLC

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91081414
Position Id: 9124148
Posted 1 day ago

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Contact the job poster

Munesh Reddy

Recruiter @ Cyber Sphere LLC

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Remote

•

Yesterday

Job Title: FDA Medical Validation Engineer Remote Contract Position Description The validation engineer utilizes validation and integration strategies to assure manufacturing equipment, computer/automated systems (software), utilities and processes used to manufacture Client s Health products are validated in accordance with applicable national and international regulations, Client s Health policies and procedures, and industry standards. This individual will assist the company to develop and im

Easy Apply

Contract

Depends on Experience

Computer Systems Validation Engineer

Remote

•

Today

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Full-time

USD 150,000.00 - 178,000.00 per year

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

•

Today

Job Description Scope: The Senior Computer Systems Validation Engineer is responsible for validation of global computer systems, monitoring changes with regulations, and assists team members for CSI's corporate Computer Systems Validation (CSV) strategy to meet all applicable regulations. Job Summary: The Senior Computer Systems Validation Engineer provides strategic leadership and technical expertise for the validation, maintenance, and continuous improvement of computerized systems used in

Full-time

USD 96,441.00 - 126,000.00 per year

Engineer Pharma Validation

Remote

•

Today

Job Summary Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing reval

Full-time

USD 79,000.00 - 119,000.00 per year