What are the responsibilities and job description for the Senior CQV Engineer position at Katalyst Healthcares & Life Sciences?
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.
- 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.
Salary : $81,604 - $122,080