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Job

CSV Engineer

  • Location

    Dublin

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    60,000 Euros

  • Contact:

    Ellen Hickey

  • Contact email:

    e.hickey@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2019-10-25

  • Startdate:

    ASAP

A global healthcare company dedicated to improving the health and well-being of people around the world are looking for a talented CSV Engineer to join them in Dublin. They built a brand new site, thus are offering the unique opportunity to be a part of a greenfield project.

In 2019, their workforce has grown by 16% to 21,230 employees worldwide. They operate in 30 countries and 13 production sites worldwide. With international expansion as a major strategic focus for the company, they believe having a diverse team will remain a key component to their future success.

They are looking for an individual with that can fulfill these requirements:

  • Subject matter expert for CSV Computer systems validation
  • Validation of automation systems for a new plant 
  • Support all aspects of Computer System Validation projects
  • Author and execute CSV documents: Validation Project Plans, User and Functional Requirements, Design Specifications, Risk Management tools, GxP and Electronic Records

(ER) / Electronic Signature (ES) assessments, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) protocols, Enhanced Design Reviews, Final Reports, and Deviation Handling. 

  • Confident in 21CFRP11 knowledge and ability to develop strategies to address gaps as they are identified.
  • Clean room and biologics experience a plus.

 

Apply Now

You can apply for this role by sending us your CV or by calling us now!

Ellen Hickey

Specialist Validation & C&Q Recruiter

Contact: 0203 675 2956 or email e.hickey@hamlynwilliams.com.

 

We recruit for a variety of opportunities in Life Sciences so feel free to get in touch with us to find out how we can help you.

You can learn more about me by looking me up on LinkedIn. Search for Ellen Hickey https://www.linkedin.com/in/ellen-hickey-609a33b7/.