FUJIFILM Diosynth Biotechnologies
FUJIFILM Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. This biomanufacturing facility will provide additional Cell Culture and Viral Gene Therapy cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025.
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
The Director of Validation is responsible for establishing and sustaining the FDBK validation strategy to support first-time quality outcomes and regulatory compliance for the development and cGMP manufacturing of a diverse range of biopharmaceutical products.
The Director of Validation will have oversight of the FDBK Validation department and related activities including Qualification and re-qualification of facilities, utilities, equipment and computerized systems. The Director of Validation will work closely with cross-functional stakeholders at the site and will coordinate with other validation leaders across the network to share best practices and enhance program alignment.
Qualifications and Experience
- Bachelor’s degree in Chemical Engineering, Process Engineering, or a related field; advanced degree preferred
- Eight (8) or more years experience in validation within the biopharmaceutical industry.
- Experience of the design, installation, commissioning of plant and/or process equipment
- Experience of validating plant and process equipment for use in a GMP manufacturing environment
- Experience of ensuring process safety using Engineering Modification systems, Hazop, or pressure systems assessment
- Experience of presenting procedures and processes in safety and quality audits (regulatory/customer)
- Proven track record in managing validation projects and teams.
- A minimum of 3 years as a line manager, with demonstrated capability to develop junior engineers
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 9 December 2024
Director of Validation Person Spec
Director of Validation JD