Commissioning Qualification Validation Engineer
2 weeks ago
DescriptionPiper 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 packageKeywords Commissioning, Qualification, Validation, Engineer, Facility build, Laboratory Equipment, IQ/OQ/PQ, Vendor Management, Pharmaceutical Manufacturing #LI-ONSITE #LI-DF1
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Indianapolis, IN, United States Piper Companies Full timeDescription 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...
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Director - Commissioning and Qualification
2 weeks ago
Indianapolis, United States Eli Lilly Full timeGlobal Facilities Delivery Commissioning And Qualification DirectorAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the...
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Director - Commissioning and Qualification
2 weeks ago
Indianapolis, United States Eli Lilly and Company Full timeAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
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Qualification and Validation Analyst
2 weeks ago
Indianapolis, IN, United States TCS USAAvance Consulting Full timeMust Have Technical/Functional Skills Experience in executing equipment validation including IQ/PQ/OQ in regulated environment Experience supporting in a GMP environment Excellent written and verbal communication skills Roles & Responsibilities Author equipment qualification and validation packages Plan coordination with equipment manufacturer or supplier...
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Qualification and Validation Analyst
2 weeks ago
Indianapolis, IN, United States TCS USAAvance Consulting Full timeMust Have Technical/Functional Skills Experience in executing equipment validation including IQ/PQ/OQ in regulated environment Experience supporting in a GMP environment Excellent written and verbal communication skills Roles & Responsibilities Author equipment qualification and validation packages Plan coordination with equipment manufacturer or supplier...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Indianapolis, IN, United States ClifyX Full timeMandatory skills* Well versed with Manufacturing, Quality and engineering system and their validations. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification . Desired skills* OT System Qualification (Radio ligand Therapy or critical dosage forms will be a...
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Validation Engineer
4 weeks ago
Indianapolis, United States Process Alliance Full timeJob Title: Validation EngineerLocation: On-SiteOverview:We’re hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment. This role is ideal for someone with strong documentation skills and experience working with electronic systems, validation deliverables, and...
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Validation Engineer
4 weeks ago
Indianapolis, United States Process Alliance Full timeJob Title: Validation EngineerLocation: On-SiteOverview:We’re hiring a Validation Engineer to support Computer System Validation (CSV) and system qualification activities in a regulated pharmaceutical environment. This role is ideal for someone with strong documentation skills and experience working with electronic systems, validation deliverables, and...
