Validation Engineer - 167994

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 is currently looking for an experienced (CQV) 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) 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) 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) 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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