- Syner-G BioPharma Group (Boston, MA)
- …and execution of validation protocols for various types of processes. The Validation Engineer will be responsible for driving overall quality performance and ... to market faster, at scale, and with the highest quality . Our team partners with a diverse range of...is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER POSITION OVERVIEW : Syner-G is seeking an experienced… more
- Curia (Albany, NY)
- CSV Systems Engineer II/III in Albany, NY...power to save lives. The CSV Systems Engineer will be responsible for supporting Quality Management ... provide guidance and expertise on various global and site CSV projects to ensure that quality teams...Preferred + Experience in the pharmaceutical industry Pay Range: CSV Systems Engineer II: $73,000-$112,000 per year.… more
- Advanced Energy (Milpitas, CA)
- Field Applications Engineer **ABOUT ADVANCED ENERGY** Advanced Energy (Nasdaq: AEIS) is a global leader in the design and manufacturing of highly engineered, ... is headquartered in Denver, Colorado. **POSITION SUMMARY:** The Sr. Field Applications Engineer is responsible for providing the sales account team, the corporate… more
- Insight Global (San Francisco, CA)
- …* Ensure computerized systems and software used in support of manufacturing, quality management, and other GxP activities are developed, validated and maintained in ... FDA, EU and other international regulations and ISO standards. * Support quality risk assessment activities (eg, system level risk assessment, functional risk… more
- Bristol Myers Squibb (Devens, MA)
- …investigations or change controls, deviation ownership of computerized system events, and CSV activities. + Interact with Infinity ( Quality Management System) to ... their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Engineer , IT Computer System Validation, Cell Therapy Devens role will… more
- Lilly (Lebanon, IN)
- …and standardization. * Provide periodic status updates to Project Management * Devise CSV and quality strategies for control systems in collaboration with Site ... better for people around the world. The Senior Principal Engineer - Automation Engineering will work as a member...site and/or for capital projects. This role will provide CSV support leading and executing CSV activities… more
- Insight Global (Danvers, MA)
- Job Description Insight Global is hiring for a CSV Engineer for our medical device client in Danvers, MA. We are seeking a Computer System Validation ( CSV ) ... initiatives. Key Responsibilities: -Develop and execute remediation activities for CSV processes to assess, plan, and enhance validation practices. -Create… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems Engineer Summary: The Senior Validation Specialist, assists with the validation activities throughout the plant, ... to Engineering Services, R&D, Production, Maintenance and QA/QC in Validation and Quality Assurance-related issues. This role serves as a source of expertise in… more
- Mentor Technical Group (PR)
- …initiates corrective action of problems and deficiencies to ensure product quality . Develops manufacturing processes that are applicable to statistical process ... Qualifications Requirements/Knowledge/Education/Skills: + BBA in Engineering + Knowledge in CSV + Problem Solving Knowledge (Yellow or Green Belt knowledge)… more
- Mentor Technical Group (Caguas, PR)
- …equipment. + Support maintenance and calibration functions to improve compliance and quality . + Provide expertise in troubleshooting and root cause investigations. + ... are a plus. + Strong understanding of regulatory requirements and quality standards. + Excellent analytical, problem-solving, and communication skills. + Ability… more
- Pfizer (Rocky Mount, NC)
- …unwavering commitment to delivering safe and effective products to patients. Our quality culture, rooted in science and risk-based compliance, is both flexible and ... ensuring that our products meet the highest standards of quality and safety. As part of this role, the...and safety. As part of this role, the lead Engineer is expected to serve as SME for site… more
- Lilly (Indianapolis, IN)
- …reducing costs and environmental impact. The Lilly Medicine Foundry QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment ... and computer systems (CSQ) within the Foundry and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes… more
- US Tech Solutions (San Bruno, CA)
- …for a person based on a comprehensive view of the evidence. **Responsibilities:** ** Quality Assurance Champion:** 1. Act as a champion of Quality Assurance ... and corporate requirements. **Regulatory Compliance:** 1. Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best practices from… more
- Delmock Technologies, Inc (Baltimore, MD)
- …validation. Experience testing structured and semi-structured data (JSON, XML, Parquet, Avro, CSV ) and comparisons Experience with data quality frameworks and ... is remote. Role: Delmock Technologies, Inc. is seeking a highly skilled Data Engineer Tester to join our team. The ideal candidate will have strong expertise… more
- System One (Washington, DC)
- …in problem solving and data manipulation through software programming. The Data Engineer ensures solution quality by performing unit testing and collaborating ... Job Title: Data Engineer Location: Remote - Eastern Time Zone Type:...model data objects, data mapping, data transformation, and data quality rules. + Work closely with technical leads and… more
- PACIV (Indianapolis, IN)
- …to regulated environments. We are seeking a detail-oriented and proactive Validation Engineer II for our Indianapolis, IN office to support compliance and efficiency ... deficiencies resulting from Periodic Reviews. + Update Computer System Validation ( CSV ) documentation which may include design documents, local policies and… more
- System One (Strongsville, OH)
- Position Title: Senior Big Data Engineer (Python/PySpark) Provide locations/flexible work by preference: 1. Pittsburgh PA - Two PNC Plaza OR Cleveland OH - ... NumPy and MatPlotLib. With experience working with file based systems(supporting csv /parquet/) + Extensive knowledge in understanding Data and creating Data… more
- Quality Consulting Group (Juncos, PR)
- QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and ... characterization, OQ, PQ] (not cleaning process) and equipment qualification [ CSV : URS, FAT, IQ, OQ, PQ, TMV] (not laboratory)....Must be available to work all shifts and overtime. Quality Consulting Group, LLC is an equal opportunity employer,… more
- Quality Consulting Group (Juncos, PR)
- QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and ... + Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as… more
- Kratos Defense & Security Solutions, Inc. (Colorado Springs, CO)
- …for our customers, our partners and ourselves. Kratos is seeking a Chief Project Engineer for SATCOM and Space Ground System projects of varying size and complexity. ... The Chief Project Engineer provides technical leadership throughout the entire engineering lifecycle;...and interfaces with other internal organizations such as Production, Quality , Customer Support and others, as well as interfaces… more
