CQV Engineer: Pharma Equipment Validation & Compliance

Piper Companies; Titusville (NJ); Presencial; USD 100.000 - 150.000; Tempo integral

Benefícios oferecidos por esta vaga

Health, Vision, Dental insurance

Comprehensive benefits package

Resumo da vaga

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer for our Titusville, NJ site. The role involves developing and executing IQ/OQ/PQ validation protocols for new instruments and ensuring compliance with regulatory guidelines.

You will work with manufacturing and cross-functional teams to complete validation activities, perform risk assessments, and help maintain SOPs related to equipment validation.

Qualificações

• Bachelor's degree in Engineering or related field.
• 5+ years in equipment commissioning and validation in pharma/medical device manufacturing.
• Strong knowledge of FDA, EU, ICH guidelines on validation.

Responsabilidades

• Develop IQ/OQ/PQ protocols for new equipment.
• Execute validation testing and generate reports.
• Provide technical support to manufacturing and troubleshoot issues.
• Collaborate with cross-functional teams to complete validation activities.
• Participate in risk assessments and mitigation recommendations.
• Assist in SOP development for equipment validation and qualification.
• Stay up-to-date with industry trends and regulations.

Conhecimentos

CQV experience

IQ/OQ/PQ expertise

Regulatory knowledge

Problem solving

Cross-functional collaboration

Independent worker

Formação

Bachelor's degree in Engineering

Descrição da vaga

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer for our Titusville, NJ site. The role involves developing and executing IQ/OQ/PQ validation protocols for new instruments and ensuring compliance with regulatory guidelines.

You will work with manufacturing and cross-functional teams to complete validation activities, perform risk assessments, and help maintain SOPs related to equipment validation.