Commissioning Qualification Validation Engineer

Description

Piper Companiesis currently looking for an experiencedCommissioning 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