Senior CQV Engineer 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.