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profile Job Location:

Carolina - USA

profile Monthly Salary: Not Disclosed
Posted on: 30+ days ago
Vacancies: 1 Vacancy

Job Summary

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

WHAT MAKES YOU A FIT:
The Technical Part:

  • Bachelors Degree in Life Science or Engineering andpreviousyears of exposure 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:
  • Process Commissioning and Qualification.
  • Validation coordination activities.
  • 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)
  • Development of an overall level 3 CQ plan in conjunction with the Client project and delivering key project milestones.
  • Lead various weekly multidisciplinary CQV Eng CM and USER coordination chart maintenance and resourcing.
  • HSE and Safe Start-Up including LOTO. CQV Doc Preparation. CQV Execution Readiness. CQV Execution. PID Walk down and Punch item Categorization.
  • Deviation Management & Change Control (Process and Automation). Punch List Management Vendor Management.
  • Developing and Reviewing CQ test plans and specifications prior to their approvals.
  • Development and maintenance of training material matrix and files for all those involved in CQV activities (Integrator CSV provider Vendors Client USERs).
  • Management and Filing of CQV related documentation.
  • Management: Compliance with a schedule at a system and area level with the planned resource levels.
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:

Manager

For Validation and Commissioning &Qualification support in the Engineering area.WHAT MAKES YOU A FIT:The Technical Part:Bachelors Degree in Life Science or Engineering andpreviousyears of exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry. Bilingual (Spanis...
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Key Skills

  • Administrative Skills
  • Facilities Management
  • Biotechnology
  • Creative Production
  • Design And Estimation
  • Architecture

About Company

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F I T S, LLC FLEXIBLE & INTEGRATED TECHNICAL SERVICES

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