Se nior QC Instrument Lifecycle Validation Engineer Devens, MA Hybrid Role: 4 days onsite/1 day ... Quality management system experience including document control/management, change controls ...
60 Systems Engineering Validation Engineer Jobs Hiring Near You
Se nior QC Instrument Lifecycle Validation Engineer Devens, MA Hybrid Role: 4 days onsite/1 day ... Quality management system experience including document control/management, change controls ...
Engineering - Validation Engineer
Summit, NJ ยท On-site
The Equipment Validation Engineer supports the successful implementation of various process/lab ... systems in a qualified / validated state according to established policies and procedures. The ...
Engineering - Validation Engineer
Summit, NJ ยท On-site
The Equipment Validation Engineer supports the successful implementation of various process/lab ... systems in a qualified / validated state according to established policies and procedures. The ...
Validation Engineer
North Haven, CT ยท On-site
Troubleshoot complex automated systems including robotics, motion control, and machine vision ... engineering/validation experience (8+ with Master's) * Strong expertise in medical device process ...
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Validation Engineer
North Haven, CT ยท On-site
Troubleshoot complex automated systems including robotics, motion control, and machine vision ... engineering/validation experience (8+ with Master's) * Strong expertise in medical device process ...
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL ยท On-site
$70K - $100K/yr
Work on validation of lab systems, equipment, and utilities * Partner with engineering, validation teams, and lab stakeholders * Assist with project scheduling, coordination, and resource planning
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL ยท On-site
$70K - $100K/yr
Work on validation of lab systems, equipment, and utilities * Partner with engineering, validation teams, and lab stakeholders * Assist with project scheduling, coordination, and resource planning
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Document management systems (e.g., Windchill preferred) Key Skills * Strong analytical and problem ...
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Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... Document management systems (e.g., Windchill preferred) Key Skills * Strong analytical and problem ...
In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for new processor silicon interface ...
In this role, this engineer will be part of a highly technical team that develops test plans, completes functional & electrical validation, & debugs issues for new processor silicon interface ...
Test and Validation Engineer
Grand Rapids, MI ยท On-site
$90K - $113K/yr
... systems engineering practices, including the V Model, to product validation activities. We offer ... Career Development Competitive Compensation and Benefits Pay Transparency Global Opportunities ...
Test and Validation Engineer
Grand Rapids, MI ยท On-site
$90K - $113K/yr
... systems engineering practices, including the V Model, to product validation activities. We offer ... Career Development Competitive Compensation and Benefits Pay Transparency Global Opportunities ...
Experience supporting various manufacturing equipment and/or systems, as well as Cleaning Validation. * Among other related activities. At Validation & Engineering Group, people always come first. We ...
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Experience supporting various manufacturing equipment and/or systems, as well as Cleaning Validation. * Among other related activities. At Validation & Engineering Group, people always come first. We ...
Validation Engineer - Manistee Area
Manistee, MI ยท On-site
$76K - $116K/yr
Advanced degree in a relevant engineering or scientific field. * Experience with automation systems (e.g., PLC, SCADA, DCS). Job Titles That Should Apply Validation Engineer, Senior Validation ...
Validation Engineer - Manistee Area
Manistee, MI ยท On-site
$76K - $116K/yr
Advanced degree in a relevant engineering or scientific field. * Experience with automation systems (e.g., PLC, SCADA, DCS). Job Titles That Should Apply Validation Engineer, Senior Validation ...
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Apply statistical analysis and SPC systems to support data-driven decision-making. * Manage ...
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Apply statistical analysis and SPC systems to support data-driven decision-making. * Manage ...
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Apply statistical analysis and SPC systems to support data-driven decision-making. * Manage ...
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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions ... Apply statistical analysis and SPC systems to support data-driven decision-making. * Manage ...
Validation Engineer - Hart Area
Hart, MI ยท On-site
$81K - $121K/yr
Support the lifecycle management of validated systems, including revalidation and change control. * Collaborate with engineering, quality, and production teams to ensure successful project execution.
Validation Engineer - Hart Area
Hart, MI ยท On-site
$81K - $121K/yr
Support the lifecycle management of validated systems, including revalidation and change control. * Collaborate with engineering, quality, and production teams to ensure successful project execution.
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
PR ยท On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
PR ยท On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
D05 - ENGINEERING / VALIDATION - Computer System Validation Engineer
Bothell, WA ยท On-site
$76.61 - $81.25/hr
Computer System Validation Engineer Job Number: 26-00988 Be part of a company that delivers life ... The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute ...
D05 - ENGINEERING / VALIDATION - Computer System Validation Engineer
Bothell, WA ยท On-site
$76.61 - $81.25/hr
Computer System Validation Engineer Job Number: 26-00988 Be part of a company that delivers life ... The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
PR ยท On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
PR ยท On-site
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Quick apply
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who ... The Validation Engineer will be responsible for validating equipment, processes, and systems used ...
Systems Engineering Jobs Information

Contractor
Posted 16 days ago
Job description
Se nior QC Instrument Lifecycle Validation Engineer
Devens, MA
Hybrid Role: 4 days onsite/1 day work from home (Manager will adjust schedule as the business/project needs are required.)
Responsibilities will include (but not limited to):
Act as the project lead for qualification of QC equipment and its associated software
Design, execute, manage, and implement QC instrument/software qualification documents such as (but not limited to): User Requirement Specification (URS), Design Qualification (DQ), validation plans, equipment IOQ protocols, software test scripts, configuration specifications, risk assessments, qualification summary report
Author/execute computer system validation scripts
Own change controls specific to the qualification of QC instruments and its associated software
Update the asset management database to reflect new assets, calibrations, preventative maintenances
Author instrument operational SOPs as needed
Coordinate/interface/host vendors on site
Champions qualification deviations/software defects, identifying root causes and Corrective Actions/Preventive Actions (CA/Client)
Acts as the liaison between Digital Plant (IT) and lab departments
Complete decommissioning/periodic assessments
Education, Qualifications and Experience Required:
Bachelor's degree in relevant scientific, engineering, or computer-based area with 6 10+ years experience in the biopharmaceutical industry or equivalent combination of education and validation/CSV/lab experience.
Quality management system experience including document control/management, change controls, investigations, deviations, electronic validation databases, asset management database
Knowledge of cGMP regulatory requirements, computerized analytical systems, i.e., 21 CFR part 11, GAMP, electronic record/electronic signature, data integrity, disaster recovery
Incumbents must have demonstrated experience in solving complex technical issues and have the skills and understanding to troubleshoot process defects
Demonstrated success in cross functional influencing, strong communication, and collaboration skills
Working knowledge of laboratory systems such as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
Must have equipment validation experience
Must have GMP experience
Must have Quality Management System (QMS) experience
Experience in Computer System Validation is a plus.
Experience in any asset management software is a plus.