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Senior Validation Engineer

Katalyst Healthcares and Lifesciences

Rochester, New York • Today

Full-time

Sr AI Validation Engineer

Cloud Destinations LLC

Remote • 9d ago

Easy Apply

Contract

$80 - $90

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Platform Software Validation Engineer | Remote

Apetan Consulting

Remote • 2d ago

Easy Apply

Contract, Third Party

$45 - $70

Staff Systems Engineer - Release Strategy & Validation

Torc Robotics

Remote or Ann Arbor, Michigan • Today

Full-time

USD 168,800.00 - 202,600.00 per year

Post-Silicon Systems Software Validation Engineer

Arrow Electronics, Inc.

Remote or California • Today

Full-time

USD 87,400.00 - 165,000.00 per year

Integration Validation Engineer- VHA Finance

HigherEchelon

Remote • Today

Full-time

Sr Generative AI Scientist II - (Model Risk & Validation)

Cotiviti

Remote • Today

Full-time

USD 145,000.00 - 170,000.00 per year

Engineer Pharma Validation

Medline Industries, LP

Remote • Today

Full-time

USD 73,000.00 - 110,000.00 per year

Validation Engineer

Katalyst Healthcares and Lifesciences

Rochester, New York • Today

Full-time

QA Analyst - UI & Data Validation (Remote)

Kforce Technology Staffing

Remote or Commerce, California • Today

Contract

$35 - $50 hourly

Data Center Infrastructure Validation - Innovation Lead

EPRI

Remote or Washington, District of Columbia • Today

Full-time

USD 185,000.00 - 200,000.00 per year

Senior Systems Data Scientist, Behavior Validation

General Motors

Remote or Sunnyvale, California • Today

Full-time

USD 148,000.00 - 226,200.00 per year

Job Details

Skills

Research and Development
Project Implementation
Regulatory Compliance
Production Engineering
Workflow
Manufacturing
Medical Devices
ISO 13485
Quality Management
ISO 9000
Risk Management
IQ
OQ
PQ
Documentation
Technical Writing
Collaboration
Management
Offshoring
Project Management
Performance Management
Preventive Maintenance
Profit And Loss

Summary

Summary:
We are seeking a highly skilled R&D/Validation Engineer with mandatory experience in the Medical Devices domain. The ideal candidate will be responsible for planning, leading, and coordinating project execution and validation activities in strict alignment
with ISO 13485 and ISO 14971 standards. This role requires a hands-on leader who can manage equipment, process, and product transfers while liaising with global teams and customers to ensure on-time delivery.
Roles & Responsibilities:

Project Leadership: Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
Validation Execution: Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification),and PQ (Performance Qualification).
Documentation & Compliance: Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations.
Cross-Functional Collaboration: Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
Stakeholder Coordination: Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery.Strategic Contribution: Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones is an added advantage.

Skills & Qualifications:

Domain Expertise: Mandatory prior experience in the Medical Devices industry.
Regulatory Knowledge: Deep understanding of ISO 13485 (Quality Management) and ISO 14971 (Risk Management).
Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
Experience as a PM/PL handling full project lifecycles.

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: 91116760
Position Id: 4c3e0e2489a133242ecf2ab0cce95daf
Posted 11 days ago

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Validation Engineer II

New York

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description Validation Engineer II Grand Island, NY | On-site - Relocation assistance is not available. Candidates must be legally authorized to work in the United States without sponsorship. Employment is contingent upon successful

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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 73,000.00 - 110,000.00 per year

Senior Engineer, Process Validation

Remote

•

Today

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the spee

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USD 100,000.00 - 130,000.00 per year

Staff Chemical Engineer, NPI & Transfers

No location provided

•

Today

Job Description Responsible for supporting process development and improvements for medical devices for both existing and new product development, production, and processes. This includes working closely with R&D at the early phases of product development to create manufacturing specifications, maintain, and enhance product processes, and design fixtures and equipment, testing processes, equipment, and validate test methods, and select raw materials to ensure that the concepts and prototypes me

Full-time

USD 116,706.01 - 145,882.52 per year

Job Details

Skills

Research and Development
Project Implementation
Regulatory Compliance
Production Engineering
Workflow
Manufacturing
Medical Devices
ISO 13485
Quality Management
ISO 9000
Risk Management
IQ
OQ
PQ
Documentation
Technical Writing
Collaboration
Management
Offshoring
Project Management
Performance Management
Preventive Maintenance
Profit And Loss

Summary

Project Leadership: Plan, lead, and coordinate project execution and validation activities, ensuring compliance with regulatory standards (ISO 13485, ISO 14971).
Validation Execution: Support and execute validation planning and protocols for equipment, process, and product transfers, specifically managing IQ (Installation Qualification), OQ (Operational Qualification),and PQ (Performance Qualification).
Documentation & Compliance: Author, review, and approve validation documentation, ensuring traceability and adherence to quality system regulations.
Cross-Functional Collaboration: Collaborate effectively with cross-functional teams (Quality, Production, Engineering) to resolve technical issues and streamline project workflows.
Stakeholder Coordination: Act as the primary point of contact, coordinating with customers, manufacturing plants, and off-shore teams to ensure project continuity and timely delivery.Strategic Contribution: Contribute as a Project Manager (PM) or Project Lead (PL) to drive project milestones is an added advantage.

Skills & Qualifications:

Domain Expertise: Mandatory prior experience in the Medical Devices industry.
Regulatory Knowledge: Deep understanding of ISO 13485 (Quality Management) and ISO 14971 (Risk Management).
Validation Expertise: Proven hands-on experience with IQ, OQ, and PQ protocols for equipment and process transfers.
Documentation: Strong technical writing skills for authoring and reviewing validation protocols/reports.
Coordination: Proven ability to manage cross-functional teams and global stakeholders (offshore and onshore).
Experience as a PM/PL handling full project lifecycles.

Dice Id: 91116760
Position Id: 4c3e0e2489a133242ecf2ab0cce95daf
Posted 11 days ago

Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Create job alert

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

Similar Jobs

Validation Engineer II

New York

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Engineer Pharma Validation

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USD 73,000.00 - 110,000.00 per year

Senior Engineer, Process Validation

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USD 100,000.00 - 130,000.00 per year

Staff Chemical Engineer, NPI & Transfers

No location provided

•

Today

Full-time

USD 116,706.01 - 145,882.52 per year