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Senior Validation Engineer Consultant

Katalyst Healthcares and Lifesciences

Massachusetts • Today

Full-time

Senior CQV Engineer/Senior Validation Engineer Consultant

Katalyst Healthcares and Lifesciences

Massachusetts • Today

Full-time

Senior Verification Engineer

Analog Devices, Inc.

Wilmington, Massachusetts • Today

Full-time

USD 110,385.00 - 151,808.00 per year

Senior Engineer, Design Verification Engineering

Analog Devices, Inc.

Wilmington, Massachusetts • Today

Full-time

USD 134,597.00 - 165,615.00 per year

Senior Principal Engineer, Design Verification

Marvell Semiconductor Inc.

Westborough, Massachusetts • Today

Full-time

USD 204,900.00 - 303,250.00 per year

Senior Engineer, Process Validation

Danaher Corporation

Remote • Today

Full-time

USD 100,000.00 - 130,000.00 per year

Senior Certification & Compliance Engineer

Celestica International LP

Remote • Today

Full-time

USD 102,000.00 - 135,000.00 per year

Senior Quantitative Engineer

dv01

Remote • Today

Full-time

USD 140,000.00 - 160,000.00 per year

Senior Engineering Consultant

Bureau Veritas

Remote • Today

Full-time

USD 95,000.00 per year

Senior Engineer, Quality Engineering

Entegris, Inc.

Bedford, Massachusetts • Today

Full-time

USD 85,000.00 - 114,000.00 per year

Senior Software Verification & Validation Engineer

Draper

Cambridge, Massachusetts • Today

Full-time

USD 75,000.00 per year

Job Details

Skills

Drawing
P&ID
Regulatory Compliance
SIP
Collaboration
Quality Assurance
Manufacturing
Project Implementation
Lifecycle Management
Document Management
Startups
Continuous Improvement
Biomedical Engineering
Chemical Engineering
GMP
GDP
Documentation
IQ
OQ
Management
Mapping
Chromatography

Summary

Job Description:
Senior CQV Engineer / Senior Validation Engineer with experience supporting commissioning, qualification, and validation activities for process equipment in GMP-regulated environments. Responsible for executing IQ/OQ protocols, equipment verification, temperature mapping, SIP/CIP validation activities, deviation support, and ensuring compliance with GMP/GDP standards while collaborating with Engineering, QA, and Operations teams.
Roles & Responsibilities:

Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for process equipment and utility systems.
Perform drawing walkdowns, including P&ID reviews and system verification activities to ensure equipment installation compliance.
Conduct equipment and component verification activities during commissioning and qualification phases.
Support Management of Change (MOC) activities and perform weld verification as part of validation and compliance processes.
Perform and support temperature mapping studies using data loggers and validation tools such as Ellab.
ssist with Steam-In-Place (SIP) and Clean-In-Place (CIP) execution, cycle development, and validation activities.
Identify, document, and investigate deviations encountered during qualification and validation activities.
Ensure accurate, complete, and compliant documentation in accordance with GMP and GDP requirements.
Collaborate cross-functionally with Engineering, Quality Assurance (QA), Manufacturing, and Operations teams to support project execution and validation deliverables.
Support field verification activities and ensure validation activities meet regulatory and quality standards.
Utilize validation lifecycle management systems such as eVal and support documentation management within validation systems.
Participate in equipment startup, operational readiness, and continuous improvement initiatives for validated systems and processes.

Requirements:

Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a related technical discipline preferred.
3-8 years of CQV (Commissioning, Qualification & Validation) and/or Validation Engineering experience in GMP-regulated industries.
Hands-on experience executing validation activities for process equipment and utility systems.
Strong understanding of GMP/GDP requirements and validation documentation practices.
Experience with IQ/OQ execution, field verification, and equipment qualification activities.
Proficiency with eVal validation management system; experience with ValGenesis is a plus.
Exposure to temperature mapping activities and validation tools such as Ellab preferred.
Experience working with bioprocess equipment including bioreactors, filtration systems, chromatography systems, and ultrafiltration (UF) preferred.
bility to support second-shift operations and weekend work as required.

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: 10a8ea931c68a7716dea6a1abe39fa70
Posted 30+ days ago

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Validation Engineer 2 - Product R&D

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Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious mind

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CSV Engineer

Woburn, Massachusetts

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Job Summary: We are seeking a Computer System Validation (CSV) Engineer with experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or biotechnology environment. The ideal candidate will have expertise in GAMP 5, 21 CFR Part 11, validation lifecycle documentation, and QC laboratory or manufacturing systems validation, while collaborating with cross-functional teams to ensure regulatory compliance. Roles & Responsibilities: Develop, execute, and maintain Computer S

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Lead CQV Engineer

Concord, New Hampshire

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Job Description: Lead second shift CQV execution activities across multiple systems and workstreams Coordinate daily execution priorities to recover schedule slippage and maintain timelines Interface with QA, Engineering, and Operations to resolve issues in real time Oversee execution of IQ/OQ protocols and operational verification activities Responsibilities: Drawing walkdowns Equipment and component verification Materials of Construction (MOC) and weld verification Provide oversight for temper

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Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

•

6d ago

Position Title: Sr. Supplier Quality Engineer (PHIAJP00004186) Location: Bedford MA Duration: 12 months Positions Requested: 2 Hours per Week: 40 (8 hrs/day) Notes from the manager: Major focus in experienced Process Validation, Verification across plastic, metal and electronics along with problem solving for candidates to support +700 parts for part qualification for Spectrawave products. The product contains Catheter and Console (System) products. Manufacture engineering, Product Quality, and/

Easy Apply

Contract

50 - 55

Job Details

Skills

Drawing
P&ID
Regulatory Compliance
SIP
Collaboration
Quality Assurance
Manufacturing
Project Implementation
Lifecycle Management
Document Management
Startups
Continuous Improvement
Biomedical Engineering
Chemical Engineering
GMP
GDP
Documentation
IQ
OQ
Management
Mapping
Chromatography

Summary

Execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols for process equipment and utility systems.
Perform drawing walkdowns, including P&ID reviews and system verification activities to ensure equipment installation compliance.
Conduct equipment and component verification activities during commissioning and qualification phases.
Support Management of Change (MOC) activities and perform weld verification as part of validation and compliance processes.
Perform and support temperature mapping studies using data loggers and validation tools such as Ellab.
ssist with Steam-In-Place (SIP) and Clean-In-Place (CIP) execution, cycle development, and validation activities.
Identify, document, and investigate deviations encountered during qualification and validation activities.
Ensure accurate, complete, and compliant documentation in accordance with GMP and GDP requirements.
Collaborate cross-functionally with Engineering, Quality Assurance (QA), Manufacturing, and Operations teams to support project execution and validation deliverables.
Support field verification activities and ensure validation activities meet regulatory and quality standards.
Utilize validation lifecycle management systems such as eVal and support documentation management within validation systems.
Participate in equipment startup, operational readiness, and continuous improvement initiatives for validated systems and processes.

Requirements:

Bachelor's degree in STEM, Biomedical Engineering, Chemical Engineering, or a related technical discipline preferred.
3-8 years of CQV (Commissioning, Qualification & Validation) and/or Validation Engineering experience in GMP-regulated industries.
Hands-on experience executing validation activities for process equipment and utility systems.
Strong understanding of GMP/GDP requirements and validation documentation practices.
Experience with IQ/OQ execution, field verification, and equipment qualification activities.
Proficiency with eVal validation management system; experience with ValGenesis is a plus.
Exposure to temperature mapping activities and validation tools such as Ellab preferred.
Experience working with bioprocess equipment including bioreactors, filtration systems, chromatography systems, and ultrafiltration (UF) preferred.
bility to support second-shift operations and weekend work as required.

Dice Id: 91116760
Position Id: 10a8ea931c68a7716dea6a1abe39fa70
Posted 30+ 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 2 - Product R&D

Bedford, Massachusetts

•

Today

Full-time

USD 84,900.00 - 127,300.00 per year

CSV Engineer

Woburn, Massachusetts

•

Today

Full-time

Lead CQV Engineer

Concord, New Hampshire

•

Today

Full-time

Sr. Supplier Quality Engineer (ONLY W-2 role)

Bedford, Massachusetts

•

6d ago

Easy Apply

Contract

50 - 55