Senior Validation Engineer
3 weeks ago
Job Title: Senior Validation Engineer Pay Rate: *** - *** Location: Onsite Job Description Summary: This individual will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of Commissioning, Qualification and Validation (CQV) activities for facility, utilities and manufacturing equipment. Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility. Flexible to support extended hours or second shift when needed to ensure the project's critical timeline is maintained. Major Accountability: Guide and supervise onsite installation and CQV activities of equipment/system. Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports. Perform CQV execution as assigned. Perform GMP risk assessments (incl. Sensors SRA). Provide technical trouble shooting during Startup, PQ and validation activities Develop periodic requalification plan Execute periodic requalification plan Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed. Write/revise accurate engineering documents for various production system. Independently manage and resolve deviations on equipment and systems. Participate on the assessment or implementation of special projects or initiatives with cross-functional teams. Lead complex root cause investigations Performs change assessments Preparing, scheduling, coordinating, and monitoring of assigned engineering projects. Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations. Second line escalation in case of equipment failures Driving continuous improvement from an asset perspective Reducing safety risks through simplification and error proofing machines Improving equipment reliability through equipment design modifications Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI). Set-up maintenance for new equipment (incl. spare part needs). Supply information and technical data for securing spare parts. Assist with preparation of plans for maintenance / calibration / qualifications. Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request. Assist with preparation of estimates for bids and proposals. Support internal and external audits. Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities. Provide responsive customer support with emphasis on customer satisfaction. Perform startup and commissioning activities as required. Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs Complete and provide accurate documentation, as required in cGMP operations. Use of CMMS system for documentation of relevant work. Other related duties as assigned. Minimum Requirements: Bachelor's Degree in Engineering or related field is required 5+ years of relevant experience in a GMP environment is required Previous experience in the pharmaceutical industry is required. Pharmaceutical aseptic filling experience is preferred Vendor management experience is a plus
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MV01-080725 Sr Validation Specialist
24 hours ago
Indianapolis, United States Validation & Engineering Group, Inc Full timeDepartment: Field - NB Location: Indianapolis, IN START YOUR APPLICATION Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation,...
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Project/Validation Engineer
3 weeks ago
Indianapolis, United States Project Farma Full timeJoin to apply for the Project/Validation Engineer role at Project Farma (PF) 6 days ago Be among the first 25 applicants Join to apply for the Project/Validation Engineer role at Project Farma (PF) Welcome to the forefront of innovation in cutting edge patient treatments! We are thrilled to present an incredible opportunity to join our high performing...
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Validation Engineer
4 weeks ago
Indianapolis, United States Process Alliance Full timeJob Title: Validation EngineerLocation: On-SiteOverview:Were 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 change...
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Validation Engineer
3 weeks ago
Indianapolis, United States Process Alliance LLC Full timeDirect message the job poster from Process Alliance Were 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 change...
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Validation Engineer
2 weeks ago
Indianapolis, United States Katalyst HealthCares & Life Sciences Full timeResponsibilities: Provide application/system validation expertise for standalone, enterprise, and integrated systems in a regulated (GxP) environment. Lead OT system qualification and validation, including Client/DCS integrated with manufacturing equipment. Support qualification activities in Radio Ligand Therapy (RLT) or critical dosage forms (preferred)....
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Validation Engineer
6 days ago
Indianapolis, Indiana, United States Abacus Service Corporation Full time $104,000 - $156,000 per yearJob Title: Validation Engineer - PharmaceuticalLocation: Indianapolis, IN, 46241Duration: 6+ Months Contract (possible extension of long term)Experience:Pharmaceutical: 5 years (Required)Validation/Qualification: 5 years (Preferred)AcademicBachelor's Degree in a Science, Engineering or relevant discipline5+ years relevant pharmaceutical and/or...
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Sr. Quality Engineer, Validation
2 weeks ago
Indianapolis, United States Hobbsnews Full timeAnticipated salary range:$68,500 - $97,800 Bonus eligible:No Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being. Medical, dental and vision coverage Paid time off plan Health savings account (HSA) 401k savings plan Access to wages before pay day with myFlexPay Flexible spending accounts (FSAs)...
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Senior Validation Project Lead
4 days ago
Indianapolis, United States PACIV Full timePACIV stands for Process Automation, Controls, Instrumentation, Validation.As a global leader in industrial automation, process control solutions and instrumentation, we serve clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored...
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Senior Validation Project Lead
1 week ago
Indianapolis, United States PACIV Full timePACIV stands for P rocess A utomation, C ontrols, I nstrumentation, and V alidation. As a global leader in industrial automation, process control solutions and instrumentation, we serve clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation...
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Senior Validation Project Lead
1 week ago
Indianapolis, United States PACIV Full timePACIV stands for Process Automation, Controls, Instrumentation, and Validation.As a global leader in industrial automation, process control solutions and instrumentation, we serve clients in the life sciences, pharmaceutical, medical device, food & beverage, and utilities sectors, specializing in delivering compliant, high-performance automation systems...
