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Job

Validation Compliance Engineer

  • Location

    Belgium

  • Sector:

    Life Sciences

  • Job type:

    Contract

  • Salary:

    €85 p/h

  • Contact:

    Ellen Hickey

  • Contact email:

    e.hickey@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    15 days ago

  • Duration:

    6 months

  • Expiry date:

    2019-03-10

  • Startdate:

    ASAP

Do you want to be a part of a pharmaceutical company that has global recognition and is widely admired? Is it important to you to be part of a motivated team; striving to provide and improve global medicines?

This pharmaceutical organisation is rated as one of the best in the world according to FORTUNE magazine’s annual World’s Most Admired Companies list. They are an exciting and innovative company; for the fourth consecutive time they ranked among the top three companies working to expand global access to medicines on the 2018 Access to Medicine Index.

 

Requirements:

  • Degree in Engineering preferred
  • Pharma experience preferred
  • Has good interpersonal and communication skills
  • Has good teamworking skills
  • Can demonstrate a pro-active behavior, seeing potential issues / risks / opportunities and translate these into mitigations / solutions / improvements
  • Can work well under pressure
  • Relevant technical expertise preferred (DCS systems, preferable Emerson DeltaV ; Batch Control ; ISA S88)
  • Knowledge on GAMP 5
  • Has GDP/GMP experience and mindset!
  • Fluent in Dutch with good knowledge of English (speaking, reading, writing)
  • Has experience with Compliance related tasks with regards to Hardware Acceptance Testing, Site Installation Testing, Software Acceptance Testing, Commissioning & Qualification (IQ, OQ, PQ) related to (pharm) equipment & processes, E&I and DCS
  • Has experience throughout the validation lifecycle from requirements to retirement

 

Responsibilities:

  • Will report to the project’s Validation & Compliance Lead
  • Assignment of 6 months which can potentially be extended
  • Validation / Compliance Review of Hardware Acceptance Testing, Site Installation Testing, Software / Functional Acceptance Testing, automation Commissioning & Qualification (IQ, OQ, PQ) protocols & test forms to support the execution of those test stages
  • Facilitation of Impact Assessments, Risk Assessments, Design Review, Requirements Traceability Matrices as well as the Validation / Compliance Review of these, hereby engaging with Operations, Technical Operations, Software, Equipment, Validation and QA SME’s / project team members
  • Deviation / change management review

 

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/.