Commissioning Qualification Validation Engineer

Piper Companies; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Job summary

An established industry player is seeking a Commissioning Qualification Validation Engineer to lead critical commissioning activities in a GMP-regulated environment. This role involves developing and executing qualification protocols, ensuring compliance with regulatory standards, and supporting the entire validation lifecycle. The ideal candidate will have a strong background in engineering or life sciences and experience in the biotech or pharmaceutical sectors. Join a dynamic team and contribute to innovative solutions that drive quality assurance in laboratory operations.

Benefits

Comprehensive benefits package

Qualifications

• 3-5 years of experience in CQV within a GMP-regulated environment.
• Strong knowledge of GMP, FDA, EMA, and ICH guidelines.

Responsibilities

• Lead commissioning activities for laboratory equipment and systems.
• Develop and document qualification protocols for compliance.

Skills

GMP Compliance

Validation Protocols (IQ/OQ/PQ)

Regulatory Guidelines (FDA, EMA, ICH)

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Job description

Commissioning Qualification Validation Engineer

Join to apply for the Commissioning Qualification Validation Engineer role at Piper Companies.

Job Details

Location: Raritan, New Jersey (NJ)

Company: Piper Companies

Responsibilities

• Lead commissioning activities for laboratory equipment, systems, and facilities, ensuring proper installation and functionality.
• Develop, execute, and document qualification protocols (IQ/OQ/PQ) for laboratory equipment, instruments, and systems to ensure GMP and regulatory compliance.
• Lead validation efforts for laboratory processes, methods, and equipment, supporting the entire validation lifecycle from planning to reporting.
• Prepare, review, and approve CQV documentation, including protocols, reports, and deviation investigations, ensuring compliance with quality standards.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related fields such as Biomedical, Chemical, or Mechanical Engineering.
• 3-5 years of experience in CQV within a GMP-regulated environment, preferably in biotech, pharmaceutical, or cell therapy industries.
• Strong knowledge of GMP, FDA, EMA, and ICH guidelines relevant to pharmaceutical and biotech operations.

Compensation

• Salary range: $110,000 - $140,000, depending on experience.
• Comprehensive benefits package.

Additional Details

Applications open from 3/17/2025 and will be accepted for at least 30 days.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Business Consulting and Services