- Astrix Technology (Fort Worth, TX)
- …Troubleshoot instrument issues and coordinate vendor repairs or service. + Support Computer System Validation /Software Assurance (CSV/CSA). + Assist with audits ... electronic documentation systems. + Understanding of data integrity and risk-based validation . + Instrumentation or metrology certifications (ASQ CCT, GAMP) a plus… more
- Quality Consulting Group (Juncos, PR)
- …Change control of Medical Devices + Equipment Commissioning / Qualification + Process Validation 4. Computer System Validation (CSV) + Manufacturing, ... degree in Engineering + 4 years of relevant experience + Proficient in validation process, CSV, PV + Proficient in Troubleshooting, Equipment Setups + Proficient in… more
- PCI Pharma Services (Bedford, NH)
- …experience troubleshooting complex analytical or microbiology equipment + Familiarity with computer systems validation and equipment software + Excellent ... + Own the full lifecycle of QC testing instrumentation: induction, qualification, validation , decommissioning, and beyond + Serve as the main point of contact… more
- PACIV (Indianapolis, IN)
- …knowledge of Data Historian systems, particularly OSI PI. + Understanding of Computer System Validation lifecycle and FDA regulatory requirements. + ... systems to enhance reliability, compliance, and performance. + Collaborate with the Validation Team to ensure automation systems align with regulatory and quality… more
- Lilly (Lebanon, IN)
- …both technical and non-technical audiences * Knowledge of GMP, regulatory requirements, computer system validation **Basic Requirements:** * Minimum BS in ... matter expertise on data historian systems design, development, installation, testing, validation , and lifecycle support. * Ensure solutions are delivered by system… more
- Medtronic (Juncos, PR)
- …regulatory requirements for data integrity, traceability, and cybersecurity. + Participate in Computer System Validation (CSV) and risk assessments. + Maintain ... the following and other duties may be assigned. + Develops and applies computer aided design (CAD) software engineering methods, theories and research techniques in… more
- Cook Medical (Pittsburgh, PA)
- …various reviews meetings supporting solution delivery.* Execute commissioning; supports computer system validation team's installation qualification (IQ), ... for operational ownership ofapplications and/or business intelligence solutions on computer systems providing business/IT or manufacturing support (ie ERP, eQMS,… more
- Mentor Technical Group (NC)
- …our Talent Bank. + Responsible for the development and execution of Computer System Validation (CSV) and Decommissioning deliverables for Laboratory ... is required. + Knowledge of SDLC regulations, including 21CFR part 11, computer systems validation requirements. + Must have experience in configuring… more
- PACIV (San Juan, PR)
- …+ Strong DeltaV programming skills (especially batch processes). + Experience with computer systems validation (CSV) in regulated/GMP environments. Desired Soft ... cost estimates. + Develop, review, and approve CSV documentation. + Ensure validation and compliance with policies, quality standards, and EHS regulations. +… more
- ThermoFisher Scientific (Greenville, NC)
- …and reports. + Validation related deviations and discrepancies. + Process Validation (PV), Cleaning Validation , and Computer System related protocols ... Description** The Staff QA Engineer will lead the quality oversight of validation activities with a strategic focus on continuous improvement and regulatory… more