Commissioning Qualification Validation Engineer - 173600

Piper Companies; Raritan (NJ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer in Raritan, NJ to support IQ/OQ/PQ of new instruments and equipment for manufacturing operations. You will develop validation protocols, conduct testing, generate reports, and collaborate with cross-functional teams to ensure timely validation activities.

A Bachelor's degree in Engineering and 5+ years in pharmaceutical equipment validation are required, with strong regulatory knowledge and problem-solving

Qualifications

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

Responsibilities

• Assist with development of equipment validation protocols (IQ/OQ/PQ).
• Conduct validation testing and generate validation reports.
• Provide technical support to manufacturing personnel and troubleshoot equipment issues.
• Collaborate with cross-functional teams to ensure timely validation activities.
• Participate in risk assessments and mitigation recommendations.
• Assist with SOP development and implementation for equipment validation.

Skills

5+ yrs exp

CQV validation

Problem solving

Communication

Independence

Cross-functional

Education

Bachelor's degree in Engineering

Tools

IQ/OQ/PQ protocols

Process validation

Regulatory guidelines

Job description

Piper Companies is currently looking for an experienced (CQV) Commission Qualification Validation Engineer in Raritan, NJ to work for an innovative and growing pharmaceutical organization. The primary responsibility of this role is to assist with the IQ/OQ/PQ of new instruments/equipment in support of manufacturing operations

Responsibilities for the (CQV) Commission Qualification Validation Engineer include:

• Assist with the development of equipment validation protocols (IQ/OQ/PQ) 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.

Qualifications for the (CQV) Commission Qualification Validation Engineer include:

• Bachelor's degree in Engineering or a related field.
• Minimum of 5+ years of experience in equipment commissioning and validation in a pharmaceutical or medical device manufacturing environment.
• Strong knowledge of applicable regulations and guidelines related to equipment validation (e.g., FDA, EU, ICH).
• Experience with IQ/OQ/PQ protocols, process validation, and risk assessment.
• Excellent problem‑solving skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work independently and as part of a cross‑functional team

Compensation for the (CQV) Commission Qualification Validation Engineer include:

• Compensation Range is dependent upon experience
• Comprehensive benefits package

Keywords

GMP, Pharmaceutical Manufacturing, Equipment Qualification, Equipment Commissioning, Equipment Qualification, IQ/OQ/PQ, Comprehensive Benefits Package, Health, Vision, Dental.