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C&Q Engineer
C&Q EngineerFlexible & Integrated Technical Services • Manati, USA
C&Q Engineer

C&Q Engineer

Flexible & Integrated Technical Services • Manati, USA
21 days ago
Job type
  • Full-time
Job description

For Validation and Commissioning &Qualification support in the Engineering area.

WHAT MAKES YOU A FIT :

The Technical Part :

Bachelors Degree inEngineering andpreviousexposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry.

  • Bilingual (Spanish & English)
  • Shift : Administrative and according to business needs.
  • Good skills in writing general documentation in English and using MS Office applications.
  • Experience in :
  • Validation coordination activities.
  • Commissioning and Qualification (C&Q).
  • Change Control Development.

cGMPsand Data Integrity regulations and guidelines.

The Personality Part :

  • Being self-motivated means that you are curious anxious to explore all possibilities without anyone telling you to (while also following instructions of course). It means youre creative with such an eye for detail that nothing gets past you. If this sounds like you and if you have a commitment to serving customers with high-quality research and products to embracing a diverse work culture and even to the environment you might just be what were looking for!
  • AS A PIECE OF FITS YOU WILL : (The day-to-day on the job)

  • Write execute and maintain the validation protocol on a timely basis.
  • Ensure timely thorough and complete execution of all protocols meeting FDA requirements.
  • Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
  • Ensure that documentation is thorough accurate and enteredinto the quality system on a timely basis.
  • Ensures complete and thorough investigation of all product failures batch failures and deviations associated with validation sampling and testing.
  • Develops documentation of investigations and communicates findings to ensure the chance of recurrence is significantly minimized and resolution satisfies validation requirements.
  • Protocol generation for packaging equipment qualification.
  • IOQ protocol generation Protocol executions and Final reports.
  • PQ protocol generation and execution with required reports.
  • Managementof change controls (generation routing execution and closing).

    BEING A FITS PIECE COMES WITH PERKS :

  • One of these is the excellent unmatched never-before-seen customer service of our team (trust us youll be amazed). However thats not all we have to offer. Talk with us to find out!
  • WHO WE ARE :

    We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our companys puzzle : you! We integrate Engineering Construction Maintenance Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible family-oriented and focused on our resources well-being while providing our Pharmaceutical Medical Device and Manufacturing industryclients with top-notch quality talent. Were FITS!

    Are you the Next Piece

    Required Experience :

    Junior IC

    Key Skills

    Anti Money Laundering,English Speaking,Data Entry,Food,Investigation,Adobe Indesign

    Employment Type : Contract

    Experience : years

    Vacancy : 1

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    Engineer • Manati, USA

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