Commissioning Qualification 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 Commission Qualification Validation Engineer in Raritan, NJ, for an innovative pharmaceutical organization. The role involves assisting with IQ/OQ/PQ of new instruments/equipment, ensuring compliance with relevant regulations.

Qualified candidates should have a Bachelor’s degree in Engineering, 5+ years of experience in equipment validation, and strong knowledge of FDA and ICH guidelines. The position includes opportunities for professional growth and a comprehensive benefits package.

Qualifications

• 5+ years of experience in equipment commissioning and validation in pharmaceutical or medical device manufacturing.
• Strong knowledge of FDA, EU, ICH regulations related to equipment validation.
• Experience with IQ/OQ/PQ protocols and risk assessments.

Responsibilities

• Assist with the development of validation protocols (IQ/OQ/PQ) for new instruments.
• Conduct equipment validation testing and generate validation reports.
• Provide technical support and troubleshoot equipment issues.
• Collaborate with teams to ensure validation activities are completed on time.
• Participate in risk assessments and recommend risk mitigation.
• Assist in developing standard operating procedures for equipment validation.
• Stay updated with industry trends and regulations.

Skills

Equipment commissioning and validation

Problem-solving skills

Attention to detail

Communication skills

Interpersonal skills

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

• 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

• 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

• Compensation Range is dependent upon experience.
• Comprehensive benefits package.