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FDA Medical Validation Engineer - Remote

Cyber Sphere LLC

Remote • Today

Easy Apply

Contract

Depends on Experience

Validation Engineer

Cyber Sphere LLC

Remote • Today

Easy Apply

Third Party, Contract

Depends on Experience

Validation Engineer

HonorVet Technologies

San Clemente, California • 10d ago

Easy Apply

Contract

$38.94 - $48.65

Firmware Validation Engineer

Comrise

Foster City, California • Today

Easy Apply

Contract

$$111.59

Validation Engineer

Ace Technologies, Inc.

Hopkins, Minnesota • 3d ago

Easy Apply

Contract

Depends on Experience

Virtual Validation Engineer

Aita Consulting Services,Inc.

Auburn Hills, Michigan • Yesterday

Easy Apply

Third Party, Contract

$50 - $52

Virtual Validation Engineer

PDDN Inc

Auburn Hills, Michigan • Today

Easy Apply

Full-time, Part-time, Contract, Third Party

Validation Engineer

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • 15d ago

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Warwick, Rhode Island • 15d ago

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Irvine, California • 15d ago

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Plymouth, Minnesota • 15d ago

Full-time

Validation Engineering Specialist

Croda

Alabaster, Alabama • Today

Full-time

System Validation Engineer

SUPERMICRO COMPUTER INC

San Jose, California • Today

Full-time

USD 95,000.00 - 113,000.00 per year

Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Columbus, Ohio • 15d ago

Full-time

Senior Validation Engineer

Jobot

Costa Mesa, California • Today

Full-time

USD 115,000.00 - 125,000.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Portsmouth, New Hampshire • 15d ago

Full-time

Validation Engineer

Katalyst Healthcares and Lifesciences

Boulder, Colorado • 15d ago

Full-time

Test Engineer Medical Imaging & System Verification

APN Software Services, Inc

Issaquah, Washington • Yesterday

Easy Apply

Contract

40 - 45

Validation Engineer II

Katalyst Healthcares and Lifesciences

Houston, Texas • 15d ago

Full-time

Senior Validation Engineer, Equipment (Relocation Assistance Available)

United Therapeutics

Jacksonville, Florida • Today

Full-time

Validation Engineer

Mativ

Dallas, Texas • Today

Full-time

Senior Validation Engineer

Jobot

Costa Mesa, California • Today

Full-time

USD 110,000.00 - 125,000.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Round Lake, Illinois • 15d ago

Full-time

Validation Engineer

Horizontal Talent

Foster City, California • Today

Full-time

USD 41.00 - 78.00 per hour

Product Validation Engineer

Times Microwave Systems

Wallingford, Connecticut • Today

Full-time

USD 75,000.00 - 120,000.00 per year

Validation Engineer

SiTime

Tempe, Arizona • 3d ago

Full-time

USD 93,500.00 - 128,590.00 per year

Validation Engineer

Weiss-Aug Group

Fairfield, New Jersey • Today

Full-time

USD 100,000.00 - 110,000.00 per year

Senior Validation Engineer

E Tech Group

Portsmouth, New Hampshire • Today

Full-time

Senior Validation Engineer

Panasonic

Illinois • Today

Full-time

USD 85,000.00 - 95,000.00 per year

Lead Validation Engineer

E Tech Group

Raleigh, North Carolina • Today

Full-time

Job Details

Skills

FDA Medical Validation

Summary

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 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)

Regards,

A close up of a logoDescription automatically generated

Vinay Ram

(Direct)

Suwanee, GA - 30024

An MBE & eVerify Company

Connect with me for exciting career opportunities:

Open Jobs (For Recruiters):

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: 9124149
Posted 1 hour ago

Fitment

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Contact the job poster

Ram Kumar

Recruiter @ Cyber Sphere LLC

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Similar Jobs

Validation Engineer

Remote

•

Today

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 associate

Easy Apply

Third Party, 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

Job Details

Skills

FDA Medical Validation

Summary

Job Title: FDA Medical Validation Engineer

Remote

Contract

Position Description

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)

Regards,

A close up of a logoDescription automatically generated

Vinay Ram

(Direct)

Suwanee, GA - 30024

An MBE & eVerify Company

Connect with me for exciting career opportunities:

Open Jobs (For Recruiters):

Dice Id: 91081414
Position Id: 9124149
Posted 1 hour ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Contact the job poster

Ram Kumar

Recruiter @ Cyber Sphere LLC

View Profile

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Validation Engineer

Remote

•

Today

Easy Apply

Third Party, Contract

Depends on Experience

Computer Systems Validation Engineer

Remote

•

Today

Full-time

USD 150,000.00 - 178,000.00 per year

Sr. Computer Systems Validation Engineer

Remote or Trumbull, Connecticut

•

Today

Full-time

USD 96,441.00 - 126,000.00 per year

Engineer Pharma Validation

Remote

•

Today

Full-time

USD 79,000.00 - 119,000.00 per year