What are the responsibilities and job description for the Commissioning Qualification Validation Engineer position at Zachary Piper Solutions, LLC?
Job Details
Piper Companies is currently looking for an experienced Commissioning Qualification Validation Engineer (CQV) in Durham, North Carolina (NC) to work for an innovative and growing pharmaceutical manufacturer.
Responsibilities for the Commissioning Qualification Validation Engineer (CQV) include:
Commissioning: Lead commissioning activities for new laboratory equipment, systems, and facilities, ensuring they are installed and function as intended.
Qualification: Develop, execute, and document qualification protocols (IQ/OQ/PQ) for laboratory equipment, analytical instruments, and systems to ensure compliance with GMP and regulatory standards.
Validation: Lead validation efforts for laboratory processes, methods, and equipment, ensuring the reliability, consistency, and reproducibility of results. Support the validation lifecycle of laboratory systems, from planning through execution and reporting.
Documentation: Prepare, review, and approve CQV documentation, including protocols, reports, and deviation investigations, ensuring compliance with all internal and external quality requirements.
Qualifications for the Commissioning Qualification Validation Engineer (CQV) include:
Bachelor's degree in engineering, Life Sciences, or a related field (e.g., Biomedical, Chemical, Mechanical Engineering, etc.).
Minimum of 3-5 years of experience in Commissioning, Qualification, and Validation (CQV) within a GMP regulated environment, preferably in the biotechnology, pharmaceutical, or cell therapy industry.
Strong understanding of GMP, FDA, EMA, and ICH guidelines related to pharmaceutical/biotech operations.
Compensation for the Commissioning Qualification Validation Engineer (CQV) include:
Salary Range is dependent upon experience.
Comprehensive benefits package
Responsibilities for the Commissioning Qualification Validation Engineer (CQV) include:
Commissioning: Lead commissioning activities for new laboratory equipment, systems, and facilities, ensuring they are installed and function as intended.
Qualification: Develop, execute, and document qualification protocols (IQ/OQ/PQ) for laboratory equipment, analytical instruments, and systems to ensure compliance with GMP and regulatory standards.
Validation: Lead validation efforts for laboratory processes, methods, and equipment, ensuring the reliability, consistency, and reproducibility of results. Support the validation lifecycle of laboratory systems, from planning through execution and reporting.
Documentation: Prepare, review, and approve CQV documentation, including protocols, reports, and deviation investigations, ensuring compliance with all internal and external quality requirements.
Qualifications for the Commissioning Qualification Validation Engineer (CQV) include:
Bachelor's degree in engineering, Life Sciences, or a related field (e.g., Biomedical, Chemical, Mechanical Engineering, etc.).
Minimum of 3-5 years of experience in Commissioning, Qualification, and Validation (CQV) within a GMP regulated environment, preferably in the biotechnology, pharmaceutical, or cell therapy industry.
Strong understanding of GMP, FDA, EMA, and ICH guidelines related to pharmaceutical/biotech operations.
Compensation for the Commissioning Qualification Validation Engineer (CQV) include:
Salary Range is dependent upon experience.
Comprehensive benefits package
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