Sign upLog in
AI Jobs in Indiana

Senior CQV Engineer

Katalyst Healthcares & Life Sciences
  • Bloomington, IN
  • Instant Apply
30+ days ago

Job Description

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.

Numbers & Facts

LocationBloomington, IN

Skills

  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Commissioningunmatched
  • Commissioning - Engineeringunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Datasheetsunmatched
  • Documentationunmatched
  • Electricityunmatched
  • Engineeringunmatched
  • Engineering Drawingunmatched
  • Engineering Managementunmatched
  • Equipment Specificationunmatched
  • Equipment Validationunmatched
  • Identify Issuesunmatched
  • Leadershipunmatched
  • Manufacturingunmatched
  • Manufacturing Automationunmatched
  • Manufacturing Equipmentunmatched
  • Manufacturing Systemsunmatched
  • Medical Equipmentunmatched
  • Organizational Skillsunmatched
  • Problem Solving Skillsunmatched
  • Process Validationunmatched
  • Project Engineeringunmatched
  • Project Scheduleunmatched
  • Project/Program Coordinationunmatched
  • Risk Analysisunmatched
  • Startupunmatched
  • System Start-Upunmatched
  • Team Playerunmatched
  • Technical Supportunmatched
  • Technical Writingunmatched
  • Traceabilityunmatched
  • Writing Skillsunmatched

Level up your application

Professional resume templates

Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.

Free resume templates

Resume Builder

Improve your existing resume or start from scratch and create a standout, ATS-friendly resume. Add job-specific content, download and apply.

Resume Builder