Validation Engineer/ Consultant

Azzur Group Denver , CO 80201

Posted 1 week ago

Azzur Group is looking for Validation Engineer in Denvor, CO for future consulting projects. This is great opportunity expedite your career growth through exposure to projects across multiple client sites and functions! If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!

Job Responsibilities:

  • Generates and executes life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment and processes for (re)qualification/(re)verification.
  • Writes, reviews and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
  • Writes reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
  • Writes procedures, investigations, protocols, reports change controls, etc. to support the Maintenance and Engineering departments.

Requirements

  • 2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry
  • Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
  • Required Knowledge:

    Working knowledge of FDA and cGMP regulations and documentation practices Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form Ability to define problems, collect data, establish facts and draw valid conclusions Proficient in Microsoft Word, Excel, and PowerPoint
icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Junior Validation Engineer/ Consultant

Azzur Group

Posted 2 weeks ago

VIEW JOBS 10/7/2020 12:00:00 AM 2021-01-05T00:00 <p>Azzur Group is looking for Validation Engineer in Denvor, CO for future consulting projects. This is great opportunity expedite your career growth through exposure to projects across multiple client sites and functions! If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!<br></p><p><strong>Job Responsibilities: </strong></p><ul> <li>Supports the execution of validation/verification studies (FAT, SAT, IQ, OQ, PQ) for cleaning, shipping, equipment, systems, utilities and processes for qualification/verification and/or re-qualification/re-verification.</li> <li>Performs Thermal mapping of temperature controlled chambers, warehouses, and SIP processes.</li> <li>Executes protocols and helps resolve deviations/discrepancies, analyze study data and write summary reports.</li> <li>Supports the resolution of regulatory observations or manufacturing site issues.</li> </ul><p><strong>Requirements</strong></p><ul> <li>1 year experience in a professional environment.</li> <li>Familiarity with aspects of validation.</li> <li>Proficient in Microsoft Word, Excel, and PowerPoint</li> <li>Ability to define problems, collect data, establish facts and draw valid conclusions</li> <li>Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form</li> </ul> Azzur Group Denver CO

Validation Engineer/ Consultant

Azzur Group