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Principal CSV Engineer

Billingham

Principal Computer Systems Validation Engineer

Grade – 34

Salary – £ 40,518 – £50,646

Contract – Permanent 

Post Ref –  2020ATR421

Trusted for generations, we are a CDMO partner for life. Here at FUJIFILM Diosynth Biotechnologies (FDB), passion – what we call Genki – lives inside everything we do. This is your opportunity to push the boundaries of your potential to impact where we know it matters most: human lives.

Whilst working as a Principal CSV Engineer in the Engineering team, we want you to embrace your individuality, discover your purpose, and follow what energizes, fulfills, and inspires you every day.

Reporting to the Validation Manager this role will ensure all computerised systems used to support GMP manufacture, are appropriately validated and controlled. The role includes all aspects of validation including definition of appropriate project validation strategies, preparation and review of validation documents and supplier audits.

The successful candidate will work closely with QA e-Compliance to ensure requirements for electronic data security and e-data management are defined and delivered during any implementation or upgrade project

Applications must have a degree in a software or engineering related discipline, a minimum of 5 years’ experience working with automated systems in a cGMP environment and up to data knowledge of industry regulations and best practice related to validation, data management and data integrity

About us

We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines.

We are growing and we are growing fast. With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility.

Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together.

Why work with us?

At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you.

When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer:

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

For further information, please see the attached Job description and person specification or contact the Validation Manager Colin Longstaff (colin.longstaff@fujifilm.com).Interested applicants must complete an application form and send to fdbkrecruitment@fujifilm.com no later than 31st Dec 2020.

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

Principal CSV Engineer Job Description

Principal CSV Engineer Person Spec

Application Form

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