Commissioning Qualification Validation Engineer
3 days ago
Description
Piper Companies is currently looking for an experienced Commissioning Qualification Validation Engineer (CQV) in Indianapolis, Indiana (IN).
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 dependent upon experience.
• Comprehensive benefits package
Keywords
Commissioning, Qualification, Validation, Engineer, Facility build, Laboratory Equipment, IQ/OQ/PQ, Vendor Management, Pharmaceutical Manufacturing #LI-ONSITE #LI-DF1
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