Kedrion Biopharma is seeking a highly skilled and experienced Process Engineer to join our dynamic Technology department. This role offers a unique opportunity to support the production of plasma-derived products in a cutting-edge pharmaceutical, GMP environment.
You will provide technical expertise on all aspects of process engineering, including feasibility studies, concept and detailed design, constructability, commissioning, and operation.
Reporting directly to the Head of Process Engineering, you will play a pivotal role in enhancing process reliability through root cause analysis and troubleshooting of existing processes and equipment. Additionally, you will provide critical process support to resolve quality deviations and safety incidents, ensuring our operations run smoothly and efficiently.
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.
Duties & Responsibilities:
- Providing technical expertise on cross-functional projects including process/utility improvement, technology transfer and new product introduction
- Process design and design of development studies for the scale-up of simple lab-scale processes into commercially viable large-scale operations in conjunction with R&D
- Assessing new and existing processes for reliability, quality, safety, best practice and adherence to cGMP and regulatory requirements
- Preparing data sheets, URS, commissioning plans and validation documentation
- Supporting installation and commissioning of new processes and equipment, monitoring effectiveness
- Supporting development of accurate budget estimates for capital equipment and projects
- Investigating simple engineering problems, troubleshooting existing processes and determining root cause and solutions
- Preparing mass and heat balances, design calculations, hydraulic assessments, process flow diagrams P&IDs and other engineering documentation
- Assisting with the development and implementation of site engineering standards
- Providing process safety support (HAZOP, ATEX etc). ensuring that all processes and changes that are implemented result in a safe process
- Knowledge and understanding critical process parameters and critical quality attributes/authoring and executing protocols/authoring reports. In depth understanding of ICH Q8, FDA published guidance and EudraLex Volume 4 all chapters and relevant annexes.
- Knowledge of method / equipment / process validation and some experience in implementation
- Knowledge of Regulatory expectations/Bracketing approaches to validation/understanding the pre-requisites required prior to Process Performance Qualification
- Bracketing approaches to validation. Knowledge and understanding critical process parameters and critical quality attributes (Good knowledge of ICH Q8 and specific market guidance/regulations)
- Can specify and design complex equipment e.g., vessels, distillation columns, virus filters and specify control systems with guidance
- Able commission simple process equipment e.g., pumps, filter without supervision
Skills & experience to help you within the role –
- You must have BEng and/or MEng Chemical Engineering degree
- Hands on experience within a GMP environment, ideally pharmaceutical
- Experience working as a Process Engineer
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.
- Competitive salary
- Bonus
- 25 days holiday
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- My Healthy Advantage phone app
- Virtual GP
- Cycle to work scheme
- Subsidised canteen
About us –
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!