Senior Validation Engineer (Indianapolis

Company: Process Automation - Controls.Instruments.Validati
Location: Indianapolis
Posted on: April 9, 2021

Job Description:

The Senior Validation Engineer will be responsible for the preparation, review, and approvalof quality and validation-- related documentation and ensuring compliance during manufacturing operations. This includes full execution of the System Development Lifecyle (SDLC) for an array of equipment and systems supporting manufacturing, laboratories and/or packaging processes. Specific assignments will vary based on the experience and expertise of the successful candidate, and requirements and expectations of the client. Position Requirements

• Bachelor's degree in Engineering or Technical discipline
• Minimum of eight (8) years Commissioning, Qualification, and/or Validation experience within technical/regulated industries
• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement. This includes deliverables such as Planning (Project Validation Plan or Validation Master Plan), User/Functional Requirements, Design Specifications, Design Qualification (DQ), Commissioning (FAT, SAT, Startup), Qualification Test Protocols (IQ/OQ/PQ), Process Validation (PV), Final Reporting, and support documentation (i.e. Traceability Matrices, SOP development, PMs, calibration, etc.)
• Experience with standard industry Process, Packaging, Facilities/Utilities, which may include: Control Box equipment (e.g. PLCs, HMIs, ladder logic, etc.), Packaging Labelers/Cartoners, BMS/CMS Systems (e.g. AHUs, Metasys, NAE controllers, etc.), Lab Equipment (e.g. Homogenizers, Spectrophotometers, Balances, Freezers/Coolers, etc.) and Automated in-process Filling, Assembly, and Delivery lines.
• Knowledge and experience with electronic document retention systems for approval, change control, and archiving purposes (i.e. Regulus, SharePoint, The Box, etc.)
• Knowledge of industry CSV and C&Q expectations and requirements (e.g. FDA guidelines, USP, GAMP 5, ISO, etc.)
• Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards
• Ability to lead, manage and execute large product launch/release, small capital projects, and process improvement changes related to the manufacturing systems within the site Desired Hard Skill Sets :
  • Comprehensive understanding of supporting process control systems related documentation (e.g. P&ID's, electrical drawings, certificates of conformance, etc.)
  • CSV experience, specifically around CFR Part 11 Electronic Record and Signatures
  • Experience with Data Historian, Migration, and Historian systems (i.e. OSI PI)
  • Project Management experience with the ability to lead and drive projects to completion autonomously Desired Soft Skills:
    • Comfortable with 24/7 manufacturing environment
    • Works well with others, within a team and takes accountability
    • Can handle a high-pressure, high-stress work environment
    • Result driven and self-motivated
    • Strong interpersonal and communication skills (verbal and presentation)
    • Organized, with strong computer literacy such as MS Project, Excel, etc. Other Requirements Location: Indianapolis, IN Travel: Up to 10% of the time to various suppliers, collaborators, and OEM sites outside of Indianapolis Are you authorized to work in the United States?* Yes No Do you have a minimum of 8 years Commissioning, Qualification, and/or Validation experience within technical/regulated industries?* Yes No Do you have a Bachelor's degree in Engineering or Technical discipline?* Yes No

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