Senior CQV Engineer

United Pharma; Indiana (PA); On-site; USD 110,000 - 150,000; Full time

Job summary

United Pharma is seeking a Senior CQV Engineer to provide engineering and CQV support for the implementation, modification, commissioning, startup, and qualification of manufacturing equipment and systems in a regulated manufacturing environment.

The ideal candidate will have hands‑on field experience, strong equipment knowledge, and the ability to work closely with Engineering, Manufacturing, Automation, Quality, vendors, and contractors throughout the equipment lifecycle.

Qualifications

• 5+ years of Engineering, CQV, Commissioning, Validation, or Equipment Implementation experience.
• Experience in Pharma, Biotech, Medical Device, or regulated manufacturing environments.
• Strong understanding of manufacturing equipment and equipment systems.

Responsibilities

• Support equipment design, installation, commissioning, startup, and qualification.
• Understand equipment design, functionality, controls, operation, maintainability, and intended use.
• Review P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
• Participate in equipment design reviews and provide input on operability and qualification requirements.
• Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, and Quality teams.
• Troubleshoot equipment and drive technical issues through resolution.
• Provide hands‑on field support during installation, startup, testing, and qualification.
• Author and review URS, commissioning protocols, IQ/OQ/PQ protocols and reports, risk assessments, traceability documents, and engineering studies.
• Support deviations, discrepancies, turnover, and project closeout documentation.
• Ensure CQV activities comply with project requirements, site procedures, cGMP, and Good Documentation Practices.
• Track CQV activities against project schedules and communicate risks, issues, and progress.

Skills

CQV experience

Pharma/regulatory experience

Documentation and CQV writing

Problem solving

Project coordination

Strong communication

Education

Bachelor’s degree in Engineering or Life Sciences

Equivalent industry experience

Job description

We are seeking a Senior CQV Engineer to provide engineering and CQV support for the implementation, modification, commissioning, startup, and qualification of manufacturing equipment and systems in a regulated manufacturing environment.

The ideal candidate will have strong equipment knowledge, hands‑on field experience, and the ability to work closely with Engineering, Manufacturing, Automation, Quality, vendors, and contractors throughout the equipment lifecycle.

Key Responsibilities:

• Support equipment design, installation, commissioning, startup, and qualification.
• Understand equipment design, functionality, controls, operation, maintainability, and intended use.
• Review P&IDs, equipment specifications, datasheets, electrical drawings, and vendor documentation.
• Participate in equipment design reviews and provide input on operability and qualification requirements.
• Coordinate with equipment vendors, contractors, Engineering, Manufacturing, Automation, and Quality teams.
• Troubleshoot equipment and drive technical issues through resolution.
• Provide hands‑on field support during installation, startup, testing, and qualification.
• Author and review URS, commissioning protocols, IQ/OQ/PQ protocols and reports, risk assessments, traceability documents, and engineering studies.
• Support deviations, discrepancies, turnover, and project closeout documentation.
• Ensure CQV activities comply with project requirements, site procedures, cGMP, and Good Documentation Practices.
• Track CQV activities against project schedules and communicate risks, issues, and progress.

Skills & Qualifications:

• 5+ years of Engineering, CQV, Commissioning, Validation, or Equipment Implementation experience.
• Experience in Pharma, Biotech, Medical Device, or regulated manufacturing environments.
• Strong understanding of manufacturing equipment and equipment systems.
• Hands‑on experience with equipment installation, startup, commissioning, and qualification.
• Strong knowledge of FAT, SAT, IQ, OQ & PQ.
• Ability to interpret P&IDs, engineering drawings, equipment specifications, and technical documentation.
• Strong technical writing and CQV documentation skills.
• Experience working with equipment vendors and multidisciplinary project teams.
• Strong troubleshooting, problem‑solving, communication, and project coordination skills.
• Knowledge of cGMP and Good Documentation Practices.
• Bachelor’s degree in Engineering, Life Sciences, or related technical field preferred, or equivalent industry experience.
• Must be able to work onsite in Bloomington, IN.