Technical Specialist

Kedrion Biopharma | Regulated GMP Manufacturing Environment

Kedrion Biopharma is recruiting a Technical Specialist within the Technology Group. The role provides technical expertise in support of Technology Mission Ownership objectives and contributes to the delivery, improvement and control of manufacturing processes within a regulated GMP environment.

The Technical Specialist will support process improvement activities, technical transfer, deviation investigation and change management, working in accordance with established quality systems, policies and procedures. The role operates cross‑functionally with Technology, Operations, Quality and R&D to support manufacturing performance, product quality and compliance.

Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on‑site.

• Complete tasks as assigned to support delivery of Technology Mission Ownership Objectives
• May be involved with introduction of new equipment, products and processes into production areas.
• May write or update controlled documents including SOPs and Process Instructions and where appropriate develop training material to support transfer of projects into manufacturing
• Become a technical subject matter expert (SME) for processes/projects within your scope of responsibility
• Assist in quality investigations, either by direct ownership or coordinating the resolution of specific quality records and be responsible for their on‑time closure
• Actively participate in or take the lead in the development and implementation of continuous improvement initiatives to help ensure Kedrion meets its yield, capacity and quality performance targets.
• Build relationships with colleagues across Technology, Operations, Quality and R&D to enable smooth of project goals and objectives
• As a minimum has a basic skill set for the collection, analysis and interpretation of process data and information and may have some capability for carrying out statistical analysis
• Be familiar with and able to apply the basic tools of Operational Excellence for continuous improvement and problem‑solving activities.
• Already be or able to work towards Operational Excellence accreditation as a white or yellow belt
• Write and or manage change controls or tasks assigned to them to ensure changes to processes are compliant and delivered on time in full.
• Participate in or lead quality risk assessments as appropriate to prepare for and consider the impact of any change proposals to manufacturing processes.

• Logical and systematic approach to problem solving
• Ability to communicate technical information clearly to colleagues at all levels
• Willingness to work hands‑on within manufacturing environments
• Competent in data collection, analysis and interpretation; proficiency in Excel

• Experience of protein purification techniques, including chromatography
• Industrial‑scale and/or GMP pharmaceutical manufacturing experience
• Understanding of GMP principles, quality systems and controlled documentation
• Experience supporting or delivering process changes in a regulated environment
• Experience writing SOPs and supporting training activities

• Degree or equivalent in a science or engineering‑based discipline, or relevant experience in pharmaceutical or technical manufacturing
• Continuous Improvement and project management qualifications (desirable)

We're looking for highly motivated and experienced people to drive the business forward. In return you'll be supported in developing your skills with ongoing training and career opportunities.

• Pension
• On‑site parking
• Employee assistance programme
• Virtual GP
• Cycle to work scheme
• Subsidised canteen
• Employee discounts and cash back
• Family friendly policies
• Employee recognition programme

Kedrion Biopharma is a biopharmaceutical company headquartered in Italy dedicated to collecting and fractionating blood plasma to produce and distribute plasma‑derived therapies worldwide. These treatments help manage and prevent rare, ultra‑rare, and debilitating conditions, including Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization.

The Kedrion group has numerous legacies within its brand; your employer will be Bio Products Laboratory Ltd, doing business as Kedrion Biopharma UK. Our plant is based in Elstree and counts nearly 1000 colleagues across various departments.

Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Today, the company employs 5,200 people globally who work collaboratively on our portfolio of 38 life‑enhancing plasma‑derived products distributed in over 100 countries.

Please apply today for immediate consideration!