Senior CQV Engineer

Katalyst CRO; Bloomington (IN); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Katalyst CRO in Bloomington, IN seeks an experienced CQV/Engineering professional to support implementation, modification, commissioning, and qualification of manufacturing equipment and systems.

You will review drawings, coordinate with vendors and cross-functional teams, author CQV documentation, and provide hands-on field support during installation, startup, testing, and qualification in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related discipline preferred or equivalent experience.
• 5+ years supporting engineering, commissioning, qualification, validation, or equipment implementation in regulated environments.
• Strong understanding of manufacturing equipment design, installation, operation, testing, and maintenance.
• CQV lifecycle experience: FAT, SAT, IQ/OQ/PQ.
• Ability to read engineering drawings and technical documentation.
• Proven communication and project coordination skills.
• Onsite work in Bloomington, IN.

Responsabilités

• Provide engineering and CQV support for implementation, modification, commissioning, and qualification of manufacturing equipment and systems.
• Review drawings and documentation (P&IDs, datasheets, electrical drawings, vendor docs).
• Coordinate with vendors, engineering, manufacturing, automation, quality, and stakeholders.
• Author, review, and revise CQV engineering documentation (URS, IQ/OQ/PQ, risk assessments, traceability).
• Support field activities during installation, startup, testing, and qualification.

Connaissances

CQV lifecycle knowledge

Vendor coordination

Documentation writing

Engineering troubleshooting

Formation

Bachelor's degree in Engineering or related discipline

Description du poste

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)
• IQ/OQ/PQ protocols and reports
• Traceability documentation
• 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.

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.