Senior CQV Engineer: Lead Pharma Equipment Validation

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 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.