Senior CQV Engineer

Katalyst Healthcares and Life Sciences

Bloomington, IN

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.

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Vacancy posted 16 hours ago

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