Senior CQV Validation Engineer — GMP IQ/OQ/PQ

Piper Companies; Titusville (NJ); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer to join our team in Titusville, NJ. The role focuses on developing IQ/OQ/PQ protocols, performing validation testing, and generating reports for equipment used in pharmaceutical manufacturing.

The ideal candidate has 5+ years in equipment commissioning/validation, strong regulatory knowledge (FDA/EU/ICH), and excellent problem-solving and communication skills.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 5+ years in equipment commissioning and validation in pharma/medical device manufacturing.
• Strong knowledge of FDA, EU, ICH regulations related to equipment validation.
• Experience with IQ/OQ/PQ protocols, process validation, and risk assessment.
• Excellent problem-solving skills and attention to detail.
• Strong communication and interpersonal skills.

Responsabilités

• Assist with the development of equipment validation protocols (IQ/OQ/PQ) for new instruments and ensure regulatory compliance.
• Conduct equipment validation testing and generate validation reports.
• Provide technical support to manufacturing personnel and troubleshoot equipment performance or quality issues.
• Collaborate with cross-functional teams to ensure timely completion of validation activities.
• Participate in risk assessments and provide recommendations for mitigation.
• Assist with development and implementation of SOPs related to equipment validation and qualification.
• Stay up-to-date with industry trends and regulations related to equipment validation and qualification.

Connaissances

Regulatory knowledge

Analytical thinking

Cross-functional collaboration

Problem-solving

Formation

Bachelor's degree in Engineering or related field

Outils

IQ/OQ/PQ protocols

Process validation

Risk assessment

Description du poste

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer to join our team in Titusville, NJ. The role focuses on developing IQ/OQ/PQ protocols, performing validation testing, and generating reports for equipment used in pharmaceutical manufacturing.

The ideal candidate has 5+ years in equipment commissioning/validation, strong regulatory knowledge (FDA/EU/ICH), and excellent problem-solving and communication skills.