Job Description

Are you ready to take your engineering career to the next level in a dynamic and highly regulated pharmaceutical environment? Kedrion Biopharma is seeking a Senior Process Engineer to join our Technology department, where you will play a crucial role in the production of plasma-derived products.



In this position, you will provide technical expertise across all areas of process engineering, including feasibility studies, conceptual and detailed design, constructability, commissioning, and operational support. Reporting directly to the Head of Process Engineering, you will work to improve process reliability through root cause analysis and the troubleshooting of existing systems and equipment, while ensuring quality deviations and safety incidents are effectively resolved.



With over a century of experience, the company's legacy spans multiple centres of excellence in Plasma Derived Medicinal Products (PDMPs) across the world. Your work will contribute to Kedrion goal of creating a world where scientific advancement and human compassion go together to serve patients worldwide.



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

Has in depth knowledge of a single BPL manufacturing process stream and equipment. Able to propose incremental improvements. Can own and deliver multiple tasks and subtasks in support of a major MO objective.

Uses relevant OE tools e.g., process mapping, FMEA, RCA to assigned MO activities - Should be a regular JDI contributor. Has awareness of 7 quality tools for data analysis and DMAIC. Can be an accredited white belt and may have attended yellow belt training.

Has a basic skill set for collection, analysis and interpretation of process data and information.

Participates in audits, both internal and external and deemed competent by line manager / QA to represent functional area with support. Supports department in audit inspection preparation activities and knowledgeable in relevant BPL SOPs and Policies.

Significant manufacturing experience at BPL or in previous role. Good knowledge of at least one manufacturing process performed on site and able to provide process support and troubleshoot issues. Able to operate or write instructions for specific equipment items.



Skills & experience to help you within the role -



Chemical Engineering degree

Hands on experience within a GMP environment, ideally pharmaceutical

Experience working as a Process Engineer



In return we offer -



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

Private Health Insurance

Life insurance

On-site parking

Employee assistance programme

My Healthy Advantage phone app

Virtual GP

Cycle to work scheme

Subsidised canteen



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.