Validation Engineer jobs in Indianapolis, IN

Validation Engineer prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Being a Validation Engineer may require a bachelor's degree. Typically reports to a manager or head of a unit/department. The Validation Engineer works on projects/matters of limited complexity in a support role. Work is closely managed. To be a Validation Engineer typically requires 0-2 years of related experience. (Copyright 2024 Salary.com)

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Process/Validation Engineer
  • Genezen
  • Indianapolis, IN FULL_TIME
  • JOB SUMMARY

    Responsible mid-level engineer to support site engineering and technical disciplines that support gene therapy processes which encompass facilities, maintenance, capital projects, validation, and EHS. The right individual for this position must be able to work independently and as a group contributor. This individual must be able to change directions in a fast-paced environment. This person will be responsible for project management, CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization and ensuring all project and day-to-day activities are performed and compliant to all site EHS policies and procedures while maintaining accuracy and quality from conception to completion.

    ESSENTIAL JOB FUNCTIONS

    • Prepare, schedule, coordinate and monitor their assigned engineering projects
    • Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications
    • Interact daily with internal team member and external third parties to interpret their needs and requirements and represent them in the field
    • Perform overall quality control of their work (budget, schedule, plans, personnel performance) and report regularly on project and maintenance/calibration status
    • Cooperate and communicate effectively with team members, other project participants, and upper management to assist with technical support
    • Execute, development/implementation/ maintenance of environmental and safety management systems
    • Coordinates the day-to-day implementation of the site safety and environmental policies and procedures
    • Develops and conducts periodic safety audits / assessments to evaluate compliance to facility safety & environmental policies & procedures
    • Troubleshoots equipment and systems issues and develops solutions
    • Ensure internal and external team members/contractors maintain the highest quality standards
    • Identifying deficiencies in MEP processes and developing improvements
    • Developing, initiating, and managing all phases of projects, maintenance/calibration, and EHS
    • Preparing documentation of critical analysis and providing suggestions for correcting errors across projects, maintenance/calibration, and EHS

    SPECIAL WORK REQUIREMENTS

    • Adaptability required as work schedule may change based on business needs
    • Criminal background check required
    • Other duties as assigned

    KNOWLEDGE, SKILLS AND EXPERIENCE

    EDUCATION/CERTIFCATIONS/LICENSES

    BS/BA degree in Engineering, Science, Technical or related field

    Essential

    PMP certification

    Pharmaceutical, Biomedical, or Medical Device experience

    Desired

    Desired

    ON-THE-JOB EXPERIENCE

    Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization

    Essential

    Adherence to all local, state, and governmental safety standards

    Essential

    Excellent knowledge of design and visualization software such as AutoCAD

    Essential

    Familiarity with rules, regulations, best practices, and performance standards

    Essential

    SKILLS/ABILITIES

    Advanced MS Office skills

    Essential

    Project management and supervision skills

    Essential

    Decision making ability and leadership skills

    Essential

    Time management and organization skills

    Essential

    Ability to work with multiple discipline projects

    Essential

    Work Environment

    • Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
    • Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
    • Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
    • Occasionally exposed to extremely loud noise levels
    • Spending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required

    Movement

    • Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
    • Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

    Lifting

    • Frequently lift and/or move up to 10 pounds
    • Occasionally lift and/or move up to 25 pounds

    Vision

    • Frequently utilize close vision and the ability to adjust focus

    Communication

    • Frequently required to communicate by talking, hearing, using telephone and e-mail

     

     

  • 22 Days Ago

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Validation Engineer - 1
  • CAI
  • Indianapolis, IN FULL_TIME
  • Position Description: The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment. These people are respo...
  • 23 Days Ago

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Validation Engineer Staff 2
  • CAI
  • Indianapolis, IN FULL_TIME
  • We are seeking CQV Engineers with 2-4 years' experience and we can assist with relocation costs.Position Description:The Commissioning, Qualification and Validation (CQV) Engineer will develop and exe...
  • 7 Days Ago

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Validation Engineer Senior 1
  • CAI
  • Indianapolis, IN FULL_TIME
  • We are seeking CQV Engineers with 4-8 years' experience and we can assist with relocation costs.Position Description: The CQV Engineer develops the documentation to support Commissioning, Qualificatio...
  • 7 Days Ago

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Senior Validation Engineer (MS&T)
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applica...
  • 13 Days Ago

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Validation Engineer (MS&T)
  • PSC Biotech
  • Indianapolis, IN FULL_TIME
  • PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applica...
  • 13 Days Ago

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0 Validation Engineer jobs found in Indianapolis, IN area

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Pipe Stress Analyst / Piping Mechanical Engineer
  • Chemours
  • Indianapolis, IN
  • As we create a colorful, capable and cleaner world through chemistry, we invite you to join our team to harness the powe...
  • 3/29/2024 12:00:00 AM

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Field Engineer
  • Carrier
  • Indianapolis, IN
  • **Country:** United States of America **Location:** CAI23: Carrier-Indianapolis, IN 7310 W Morris St, Indianapolis, IN, ...
  • 3/29/2024 12:00:00 AM

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Lead Validation Engineer
  • Katalyst Healthcares & Life Sciences
  • Indianapolis, IN
  • Responsibilities: For Automation Engineers who are assigned to validation projects and operate in the field, the enginee...
  • 3/28/2024 12:00:00 AM

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Industrial Air Compressor Technician
  • Brehob Corporation
  • Indianapolis, IN
  • Brehob Corporation has been serving the Industrial and Manufacturing market for over 70 years with industry leading prod...
  • 3/28/2024 12:00:00 AM

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Commissioning Technician
  • Grantek Systems Integration
  • Indianapolis, IN
  • Company Description From concept to design to execution, be part of the team that gets everyday products to people. Gran...
  • 3/28/2024 12:00:00 AM

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Product Development Engineer (16940)
  • Belden
  • Indianapolis, IN
  • Belong. Believe. Be You. Belden. Propel your career surrounded by a diverse team of innovative, goal-oriented individual...
  • 3/28/2024 12:00:00 AM

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Sustaining Engineering Technical Program Manager New Product Insertion
  • CBRE
  • Indianapolis, IN
  • Sustaining Engineering Technical Program Manager New Product Insertion Job ID 159910 Posted 20-Mar-2024 Service line GWS...
  • 3/27/2024 12:00:00 AM

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Technical Writer/Engineer
  • PSC Biotech
  • Indianapolis, IN
  • Job Description PSC Biotech provides the life sciences with essential services to ensure that health care products are d...
  • 3/25/2024 12:00:00 AM

Indianapolis is in the East North Central region of the Midwestern United States, in central Indiana. According to the U.S. Census Bureau, the Indianapolis (balance) encompasses a total area of 368.2 square miles (954 km2), of which 361.5 square miles (936 km2) is land and 6.7 square miles (17 km2) is water. The consolidated city boundaries are coterminous with Marion County, with the exception of the autonomous municipalities of Beech Grove, Lawrence, Southport, and Speedway. Indianapolis is the 16th largest city by land area in the U.S. Indianapolis is within the Tipton Till Plain, a flat to...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Validation Engineer jobs
$54,261 to $72,492
Indianapolis, Indiana area prices
were up 1.3% from a year ago

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