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18 results (1 new)

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Equipment Engineer

Katalyst Healthcares and Lifesciences

Summit, New Jersey • Today

Full-time

Equipment Sourcing Engineer

X-energy

Remote or Rockville, Maryland • Today

Full-time

USD 106,400.00 - 149,000.00 per year

Senior Software Engineer (Test Equipment Engineering)

Marotta Controls, Inc.

Parsippany-Troy Hills, New Jersey • Today

Full-time

USD 137,000.00 - 150,000.00 per year

Software Engineer III (Automated Test Equipment)

Marotta Controls, Inc.

Parsippany-Troy Hills, New Jersey • Today

Full-time

USD 110,000.00 - 123,000.00 per year

Sr. Mechanical Engineer, Test Equipment Engineering

Marotta Controls, Inc.

Parsippany-Troy Hills, New Jersey • Today

Full-time

USD 110,000.00 - 130,000.00 per year

Mechanical Engineer II (Test Equipment Engineering)

Marotta Controls, Inc.

Parsippany-Troy Hills, New Jersey • Today

Full-time

USD 87,750.00 - 115,000.00 per year

Staff Mechanical Engineer - Furnaces & Thermal Equipment

Corning

New York, New York • Today

Full-time

USD 154,744.00 per year

Principal Engineer - Packaging Equipment

Conagra Brands

Remote or Omaha, Nebraska • Today

Full-time

USD 109,000.00 - 159,000.00 per year

Project Manager

Motion Recruitment Partners, LLC

Remote or Texas • Today

Easy Apply

Contract

Field Applications Engineer

Nordson Corporation

Remote or Minnesota • Today

Full-time

USD 85,000.00 - 110,000.00 per year

Patient Monitoring/Telemetry/Diagnostic Cardiology Field Engineer 2 - Seattle Metro Area

GE Healthcare

Remote • Today

Full-time

USD 85,280.00 - 127,920.00 per year

Field Service Engineer I - Las Vegas

GE Healthcare

Remote • Today

Full-time

Patient Monitoring/Telemetry/Diagnostic Cardiology Field Engineer 1 - Central & Eastern Washington

GE Healthcare

Remote or Washington • Today

Full-time

USD 69,040.00 - 103,560.00 per year

Field Service Engineer 1 (2nd Shift) -Northeast Ohio/Cleveland Ohio Area

GE Healthcare

Remote or Cleveland, Ohio • Today

Full-time

Field Engineer 1 - Dallas TX

GE Healthcare

Remote • Today

Full-time

Surgery Field Service Engineer 1 - Richmond, VA

GE Healthcare

Remote or Richmond, Virginia • Today

Full-time

USD 66,560.00 - 99,840.00 per year

BAS Engineering Manager

DLB Associates Consulting Engineers, P.C.

Remote • Today

Full-time

USD 126,788.00 per year

Senior Engineer, Innovation

FFF Enterprises

Remote or Temecula, California • Today

Full-time

USD 160,000.00 per year

Job Details

Skills

Collaboration
Traceability Matrix
Change Management
Scheduling
Turnover
Preventive Maintenance
Technical Support
Science
GMP
Good Manufacturing Practice
GxP
GAMP
Software Development Methodology
Computerized System Validation
Documentation
Manufacturing
Corrective And Preventive Action
Pharmaceutics
Multitasking
Attention To Detail
Regulatory Compliance
Management
Microsoft Office
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Database
Data Management

Collaboration
Traceability Matrix
Change Management
Scheduling
Turnover
Preventive Maintenance
Technical Support
Science
GMP
Good Manufacturing Practice
GxP
GAMP
Software Development Methodology
Computerized System Validation
Documentation
Manufacturing
Corrective And Preventive Action
Pharmaceutics
Multitasking
Attention To Detail
Regulatory Compliance
Management
Microsoft Office
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Database
Data Management

Summary

Job Summary:

The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.

Roles & Responsibilities:

Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
Supervise vendors performing qualification activities.
Support the development of equipment operational procedures.
Support equipment validation activities and execute equipment qualification and validation protocols.
Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
Support the Change Management process.
Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
Complete qualification and validation documentation accurately and in compliance with client standards.
Review, prioritize, and respond to customer equipment qualification and support requests.
Provide technical support and guidance on equipment qualification issues.
Interface with customers to ensure expectations are met.
Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
Maintain positive working relationships with team members and site customers.
Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
Participate in deviation investigations as a Subject Matter Expert (SME), when required.

Education & Experience:

BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
Minimum of 5 years of experience performing or supporting activities in a GMP environment.
Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, Computer System Validation (CSV) requirements, and Good Documentation Practices.
Knowledge of pharmaceutical manufacturing and laboratory systems.
Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
Strong written, verbal, interpersonal, organizational, and multitasking skills.
Detail-oriented with a strong commitment to quality, safety, and compliance.
Ability to manage multiple projects and prioritize tasks effectively.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
Experience with Electronic Data Management Systems such as ValGenesis is preferred.

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: a5b58d01b0b27fa6e9bdbb22f50f911e
Posted 1 day ago

Fitment

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FSP Metrology Specialist

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Job Details

Skills

Collaboration
Traceability Matrix
Change Management
Scheduling
Turnover
Preventive Maintenance
Technical Support
Science
GMP
Good Manufacturing Practice
GxP
GAMP
Software Development Methodology
Computerized System Validation
Documentation
Manufacturing
Corrective And Preventive Action
Pharmaceutics
Multitasking
Attention To Detail
Regulatory Compliance
Management
Microsoft Office
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Database
Data Management

Collaboration
Traceability Matrix
Change Management
Scheduling
Turnover
Preventive Maintenance
Technical Support
Science
GMP
Good Manufacturing Practice
GxP
GAMP
Software Development Methodology
Computerized System Validation
Documentation
Manufacturing
Corrective And Preventive Action
Pharmaceutics
Multitasking
Attention To Detail
Regulatory Compliance
Management
Microsoft Office
Microsoft Excel
Microsoft PowerPoint
Microsoft Outlook
Database
Data Management

Summary

Job Summary:

The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.

Roles & Responsibilities:

Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
Supervise vendors performing qualification activities.
Support the development of equipment operational procedures.
Support equipment validation activities and execute equipment qualification and validation protocols.
Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
Support the Change Management process.
Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
Complete qualification and validation documentation accurately and in compliance with client standards.
Review, prioritize, and respond to customer equipment qualification and support requests.
Provide technical support and guidance on equipment qualification issues.
Interface with customers to ensure expectations are met.
Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
Maintain positive working relationships with team members and site customers.
Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
Participate in deviation investigations as a Subject Matter Expert (SME), when required.

Education & Experience:

BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
Minimum of 5 years of experience performing or supporting activities in a GMP environment.
Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, Computer System Validation (CSV) requirements, and Good Documentation Practices.
Knowledge of pharmaceutical manufacturing and laboratory systems.
Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
Strong written, verbal, interpersonal, organizational, and multitasking skills.
Detail-oriented with a strong commitment to quality, safety, and compliance.
Ability to manage multiple projects and prioritize tasks effectively.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
Experience with Electronic Data Management Systems such as ValGenesis is preferred.

Dice Id: 91116760
Position Id: a5b58d01b0b27fa6e9bdbb22f50f911e
Posted 1 day ago

Fitment

Dice Job Match Score™

⭐ Evaluating experience...

Create job alert

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

Similar Jobs

CQV Engineer, General Application

New Jersey

•

Today

Full-time

USD 5,000.00 per month

Senior Engineer I, Site Automation (Hopewell, NJ)

Hopewell, New Jersey

•

Today

Full-time

USD 114,700.00 - 154,700.00 per year

Maintenance Technician Contractor (Biotech Manufacturing)

North Plainfield, New Jersey

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15d ago

Easy Apply

Contract

FSP Metrology Specialist

New Brunswick, New Jersey

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Today

Full-time

USD 60,000.00 - 65,000.00 per year