Senior CQV Engineer

Bloomington, IN, US • Posted 18 hours ago • Updated 7 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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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.
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 18 hours ago
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