Commissioning Qualification Validation Engineer - 173600

ZP Group; Raritan (NJ); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Comprehensive benefits package

On-site work

Job summary

Piper Companies is seeking an experienced CQV Commission Qualification Validation Engineer to support IQ/OQ/PQ of new instruments in Raritan, NJ. You will assist with developing validation protocols and generate reports for manufacturing operations.

The role requires 5+ years in equipment commissioning/validation in pharma or medical devices, with strong regulatory knowledge and problem-solving skills. On-site work with a comprehensive benefits package is provided.

Qualifications

• Bachelor's degree in engineering or related field required.
• 5+ years hands-on experience in equipment commissioning and validation in pharma or medical device manufacturing.
• Strong knowledge of FDA, EU, ICH guidelines for IQ/OQ/PQ and process validation.

Responsibilities

• Assist with developing IQ/OQ/PQ validation protocols for new instruments.
• Conduct equipment validation testing and generate validation reports.
• Provide technical support to manufacturing and troubleshoot equipment issues.
• Collaborate with cross-functional teams to meet validation timelines.
• Participate in risk assessments and recommend mitigations.
• Develop and implement SOPs related to equipment validation and qualification.
• Stay up-to-date with industry trends and regulatory changes.

Skills

IQ/OQ/PQ protocols

Regulatory knowledge

Risk assessment

Communication skills

Independent work

Education

Bachelor's degree in Engineering or related field

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.

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