CQV Validation Engineer — Lead IQ/OQ/PQ for Equipment

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

Avantages offerts par ce poste

Comprehensive benefits package

Résumé du poste

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

The ideal candidate has a bachelor's degree in engineering and 5+ years in pharma equipment validation, with strong knowledge of FDA/EU/ICH guidelines and excellent problem-solving and communication skills. This is an onsite role offering a comprehensive benefits package.

Qualifications

• Bachelor's degree in Engineering or a related field required.
• Minimum 5+ years of equipment commissioning and validation experience 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 and attention to detail; strong communication skills.

Responsabilités

• Assist with development of IQ/OQ/PQ validation protocols for new instruments.
• Conduct validation testing and generate validation reports.
• Provide technical support to manufacturing and troubleshoot equipment issues.
• Collaborate with cross-functional teams to complete validation activities on time.
• Participate in risk assessments and recommend mitigation strategies.
• Assist with SOP development related to equipment validation and qualification.
• Stay updated on industry trends and regulations for validation.

Connaissances

Problem-solving

Communication

Independent work

Cross-functional collaboration

Formation

Bachelor's degree in Engineering or related field

Outils

IQ/OQ/PQ protocols

Process validation

Risk assessment

Description du poste

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

Application Period: This position opens for applications on 6/16/2026 and will remain open for a minimum of 30 days from the posting date.

Keywords

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

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