Qualification Engineer

FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; Billingham; On-site; GBP 30,000 - 60,000; Full time

Job description

FUJIFILM Diosynth Biotechnologies

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force.

Whilst working as Qualification Engineer in the Engineering team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity.

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.

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.

Role & Responsibilities

• Schedule, plan and maintain qualified status for GMP equipment and utilities across all manufacturing assets.
• Ensure best practice operating methods are deployed by providing system expertise.
• Ensure permanent inspection readiness for GMP equipment and utilities across all manufacturing assets.
• Deliver improvements to GMP equipment and utility systems through the execution of improvement plans, utilising knowledge of process performance and risks.
• Help resolve operational problems such as deviations/ QIPs/ CAPAs by helping to drive investigations.
• Act (or deputise) as VSP Owner for direct impact equipment and utilities on site.
• Maintain system records which effectively capture and convey corporate knowledge of site GMP equipment and utility systems. Write and issue operating philosophies which deliver the required availability of site services.
• Interface with internal or external technical experts and peers to maintain a broad knowledge of the technology and regulations which impact on GMP equipment and utilities.

Qualifications and Experience

• Science/ Engineering Degree or equivalent training and experience
• HVAC qualification
• LAF and MSC qualification
• Experience of following the scientific method to measure the performance of systems and processes
• Experience of working with a variety of computer systems
• The capability to write clear and concise technical documentation.
• Skilled in the following techniques:

• Thermal and biological mapping of autoclaves, fermenters and Steam In Place systems

• Thermal mapping of cold rooms, fridges and freezers

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
• 35 days of holiday, plus bank holidays.
• Salary Sacrifice scheme offering, healthcare, bikes, dental etc.
• Generous pension scheme
• Free parking and electric charging points

Closing date 25th April 2025