Qualification Engineer

Qualification Engineer

Grade – 32


Post Ref – OPS/0114

Salary – £28,409 – £35,512

Fujifilm Diosynth Biotechnologies based in Billingham, Stockton-on-Tees specialise in developing manufacturing processes for customers biologic drugs and offering stability studies to support customer drug substance and drug products.

With plants in Billingham, UK, North Carolina, USA and Texas USA our global vision is to be the leading and most trusted global Contract Development and Manufacturing Organisation partner in the biopharmaceutical industry.

As we continue on a period of significant growth we have an opportunity for a Qualification Engineer to join the Company.

We have a vision to be the best manufacturing organisation in the global Biotechnology Industry therefore we are seeking an individual who wants to be the best by demonstrating the following characteristics:

  • Dependable (does what they say they are going to do) and reliable (do it when and how they say they will, without interruption)
  • Has high quality standards and thoroughness when achieving regulatory or customer expectations

As a Qualification Engineer you will perform and plan routine activities to maintain the qualified GMP status of manufacturing equipment and systems. The routine testing and reviews you will undertake are critical to realising manufacturing operations that deliver biological medicines into our customers clinical and commercial supply chains.

You will perform and plan activities to maintain the qualification status of manufacturing (MF1/2/3/4, MCB, CBF)  services and systems including:

  • HVAC
  • MSC and LAF
  • Autoclaves
  • Clean steam
  • Process air
  • Fermenters (100L to 5000L) and CMS
  • Cold chains

Full support and training will be provided to generate and maintain the following skills:

  • Thermal mapping data acquisition, analysis and reporting for autoclave and cold chain equipment
  • Biological testing of sterilisation processes
  • Particulate testing or clean rooms
  • Air rate and integrity testing of HVAC systems
  • Steam quality testing

This is a great opportunity to become a subject matter expert on systems critical to manufacturing and to contribute to the continued cGMP compliance required to supply biologic medicinal products.

We offer a generous benefits package including;

  • Competitive salary plus company bonus scheme
  • Up to 35 days of holiday, plus bank holidays.
  • Salary Sacrifice scheme offering childcare vouchers, bikes, dental etc.
  • Free parking.
  • Generous pension scheme

For further information please contact  fdbkrecruitment@fujifilm.com

Interested applicants must complete an application form and send to the HR & OD Team no later than 12 noon on Friday 5 October 2018 (fdbkrecruitment@fujifilm.com)

If we have not contacted you within four weeks of the closing date, please assume that you have not been shortlisted on this occasion.

QE Job description


Application Form

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