Niveau: Mid-Senior level

Type d’emploi: Full-time

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le contenu du travail

Job Responsibilities

  • Perform scheduled calibrations on equipment and systems in the facility, which include Manufacturing, Analytical Labs, Utilities, and Warehouse.
  • Ability to understand critical process requirements to develop instrumentation process and calibration tolerances
  • Ability to develop and to write FMEA (Failure Mode and Effects Analyzes)
  • Ability to fully investigate Out of Tolerance, Traceability, and lead Vendor management.
  • Ability to independently drive results and work through root cause investigation for instrumentation in the field.
  • Manage and maintain instrument calibration documentation and CMMS database. Responsible for the initiation of OOS ad OOT documentation when instrumentation calibrations indicate out of tolerance or failure.
  • Review, enter, and scan all incoming calibration & PM data from outside vendors.
  • Research, recommend, and specify instrumentation to support new engineering projects, as well as improve existing equipment and operations. Manage new instrument documentation setup and calibration database integration.
  • Execute on demand calibrations utilizing the Work Order system as needed.
Job Requirements

  • Preferably 0-3 years of instrumentation and field calibration experience in a pharmaceutical environment.
  • Strong instrumentation and field calibration skills
  • Strong understanding of industrial instrumentation and measurement principals, as well as process controls.
  • Strong ability with FMEA method ( Criticality Analyzes)
  • Ability to read and understand electrical schematics, loop diagrams, and P&IDs.
  • Good troubleshooting skills; ability to analyze and diagnose instrument failures.
  • Ability to specify new or replacement instrumentation to support new engineering projects or for existing processes.
  • GMP and good documentation practices knowledge
  • Change control management
  • Demonstrated ability to work in a team environment
  • Results oriented; high level of initiative
  • Strong verbal and written communication skills
  • Must have the ability to author/review accurate and effective Standard Operating Procedures.
  • Computer skills – Microsoft Office
  • Strong CMMS knowledge, Blue Mountain preferred.
  • Demonstrated ability to work in a team environment and lead individuals/projects if necessary.
  • French required and English B1 desired
Job Conditions

  • On-call activities required for this position
***Job up***

KBI Biopharma, Inc. (KBI) is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must either (1) have provided proof of full vaccination (as defined by the CDC) with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization; or (2) perform weekly COVID-19 testing with negative test results.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.
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Date limite: 25-05-2024

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