CQV Validation Engineer — IQ/OQ/PQ for Pharma

Zachary Piper Solutions; Raritan (NJ); On-site; USD 105,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies in Raritan, NJ is seeking an experienced CQV Validation Engineer to support IQ/OQ/PQ activities for new instruments and equipment in manufacturing operations.

The role requires a Bachelor's in Engineering and 5+ years in equipment commissioning/validation within pharma or medical device environments, with strong regulatory knowledge and teamwork. You will develop protocols, conduct testing, generate reports, and provide technical support.

Qualifications

• Bachelor's degree in Engineering or related field.
• 5+ years of experience in equipment commissioning and validation.
• 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.

Responsibilities

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

Skills

IQ/OQ/PQ protocols

Equipment validation

Cross-functional teamwork

Problem-solving

Regulatory knowledge

Education

Bachelor's degree in Engineering or related field

Job description

Piper Companies in Raritan, NJ is seeking an experienced CQV Validation Engineer to support IQ/OQ/PQ activities for new instruments and equipment in manufacturing operations.

The role requires a Bachelor's in Engineering and 5+ years in equipment commissioning/validation within pharma or medical device environments, with strong regulatory knowledge and teamwork. You will develop protocols, conduct testing, generate reports, and provide technical support.