Kedrion Biopharma are recruiting for a Process Engineer to join the Technology department and support the production of plasma-derived products in a pharmaceutical, GMP environment and provide technical expertise on all aspects of process engineering including feasibility studies, concept and detailed design, constructability, commissioning, and operation etc.
Reporting into the Head of Process Engineering, the successful candidate will support and improve process reliability through root cause analysis and troubleshooting of existing processes and equipment whilst providing process support to resolve quality deviations and safety incidents.
This exciting position will offer the successful candidate the opportunity to help build a modern, positive, and strong image for the company as it grows, solidifying its presence as rank #5 leader of Plasma Derived Medicinal Products (PDMPs) for patients and customers 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 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, which collects and fractionates blood plasma to produce and distribute worldwide plasma-derived therapies for use in treating and preventing serious diseases, disorders, and conditions.
In 2022, Kedrion joined forces with BPL (Bio Products Laboratory).
Based in Elstree, BPL operates a targeted portfolio of successful plasma-derived products to treat rare diseases.
There are nearly 1000 colleagues based at the campus, where a number of our life-enhancing plasma-derived products are manufactured.
With the combination of Kedrion and BPL, the company now becomes a global player in plasma derivatives and rare disease medicines employing more than 4,800 people worldwide.
As a joint company, we function as a bridge between donors and the people who need treatment, and work on a global scale to expand patient access to plasma-derived therapies.
Please apply today for immediate consideration.