Validation Engineer

Piper Companies; Raritan (NJ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking an experienced CQV Validation Engineer in Raritan, NJ, to assist with the IQ/OQ/PQ of new instruments/equipment. This role involves developing validation protocols, conducting testing, and providing technical support to ensure compliance with regulations.

The ideal candidate should have a Bachelor's degree in Engineering and a minimum of 5 years of experience in pharmaceutical validation environments. Strong knowledge of FDA regulations and excellent problem-solving skills are essential.

Qualifications

• Minimum of 5+ years of experience in pharmaceutical equipment validation.
• Strong knowledge of regulations related to equipment validation.
• Experience with IQ/OQ/PQ protocols and risk assessments.

Responsibilities

• Assist with the development of equipment validation protocols.
• Conduct equipment validation testing and generate reports.
• Provide technical support and troubleshoot equipment issues.

Skills

Equipment commissioning and validation

Knowledge of FDA regulations

Problem-solving skills

Communication skills

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.