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Senior CQV Engineer

Katalyst Healthcares and Lifesciences

Bloomington, Indiana • Today

Full-time

Job Details

Skills

Electrical Engineering
Design Review
URS
Risk Assessment
Turnover
Management
Project Management
Testing
Life Sciences
Pharmaceutics
Biotechnology
Medical Devices
Project Engineering
Startups
Manufacturing
IQ
OQ
PQ
IDS
Technical Writing
Conflict Resolution
Problem Solving
Good Manufacturing Practice
Documentation
Communication
Project Coordination

Summary

Roles & Responsibilities:

Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
Support FAT, SAT, commissioning, and qualification activities as required.
Author, review, and revise CQV and engineering documentation, including:
User Requirements Specifications (URS)
Commissioning protocols
IQ/OQ/PQ protocols and reports
Risk assessments
Traceability documentation
Engineering studies
Deviations and discrepancy documentation
Turnover and closeout documentation
Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
Support investigation and resolution of technical issues encountered during commissioning and qualification.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
Ability to author clear and technically accurate engineering and CQV documentation.
Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
Understanding of cGMP requirements and Good Documentation Practices.
Strong communication, organizational, and project coordination skills.
Ability to work independently while effectively collaborating within multidisciplinary project teams.
Onsite work requirement in Bloomington, IN.

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: f6bccd4b4026cb7555a21aeca23e114d
Posted 19 hours ago

Fitment

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Job Details

Skills

Electrical Engineering
Design Review
URS
Risk Assessment
Turnover
Management
Project Management
Testing
Life Sciences
Pharmaceutics
Biotechnology
Medical Devices
Project Engineering
Startups
Manufacturing
IQ
OQ
PQ
IDS
Technical Writing
Conflict Resolution
Problem Solving
Good Manufacturing Practice
Documentation
Communication
Project Coordination

Summary

Roles & Responsibilities:

Provide engineering and CQV support for the implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
Develop a thorough understanding of equipment design, functionality, controls, operating principles, and intended use.
Serve as a technical resource for equipment-related issues throughout design, installation, commissioning, startup, and qualification.
Review engineering drawings and technical documentation, including P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
Support equipment design reviews and provide input regarding functionality, maintainability, operability, and qualification requirements.
Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, Quality, and other project stakeholders.
Support and/or execute equipment startup, commissioning, troubleshooting, and qualification activities.
Identify equipment and system issues and work with project teams and vendors to drive issues through resolution.
Support FAT, SAT, commissioning, and qualification activities as required.
Author, review, and revise CQV and engineering documentation, including:
User Requirements Specifications (URS)
Commissioning protocols
IQ/OQ/PQ protocols and reports
Risk assessments
Traceability documentation
Engineering studies
Deviations and discrepancy documentation
Turnover and closeout documentation
Ensure commissioning and qualification activities are appropriately documented and executed in accordance with project requirements, site procedures, and cGMP expectations.
Manage assigned engineering/CQV activities against project schedules and communicate risks, issues, and progress to project leadership.
Provide hands-on support in the field during equipment installation, startup, testing, and qualification.
Support investigation and resolution of technical issues encountered during commissioning and qualification.

Requirements:

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred, or equivalent relevant industry experience.
Approximately 5+ years of experience supporting engineering, commissioning, qualification, validation, or equipment implementation within pharmaceutical, biotechnology, medical device, or another regulated manufacturing environment.
Strong understanding of manufacturing equipment and equipment systems, including how equipment is designed, installed, operated, tested, and maintained.
Demonstrated project engineering experience supporting equipment installation, startup, commissioning, or qualification.
Experience working directly with equipment vendors, engineering teams, manufacturing personnel, and Quality.
Working knowledge of CQV lifecycle activities, including FAT, SAT, commissioning, IQ, OQ, and PQ.
Ability to read and interpret engineering drawings, equipment specifications, P&IDs, and technical documentation.
Ability to author clear and technically accurate engineering and CQV documentation.
Strong troubleshooting and problem-solving skills with the ability to identify and resolve equipment-related issues.
Understanding of cGMP requirements and Good Documentation Practices.
Strong communication, organizational, and project coordination skills.
Ability to work independently while effectively collaborating within multidisciplinary project teams.
Onsite work requirement in Bloomington, IN.

Dice Id: 91116760
Position Id: f6bccd4b4026cb7555a21aeca23e114d
Posted 19 hours 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.

Create job alert

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

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•

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