Senior Process Engineer

A global pharmaceutical organisation based in the south east of England are currently looking for an experienced Senior Process Engineer. 

Main Job Purpose
• Provide process engineering expertise for production of plasma-derived products in a pharmaceutical, GxP environment;
• Lead and provide technical expertise on all aspects of process engineering including feasibility studies, concept and detailed design, constructability, commissioning and operation etc.;
• Provide process engineering expertise on cross functional projects including process & utility improvements and technology transfer
• Support and improve process reliability through root cause analysis and troubleshooting of existing processes and equipment;
• Provide process support to resolve quality deviations and safety incidents
• Champion GEP within the department and mentor less experienced team members

Key Duties and Responsibilities
• Leading and 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 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/reviewing vendor feasibility studies, concept/detailed designs, URSs, design specifications; design/GMP reviews, commissioning plans and validation documentation
• Supporting installation, commissioning, FATs, SATs and validation of new processes and equipment, monitoring effectiveness
• Providing accurate budget estimates for capital equipment and projects;
• Investigating complex 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

Qualifications and Experience
• Chartered Engineer (Process/Chemical/ Bio-chemical Engineering)
• Minimum 4 years’ experience working in the Pharmaceutical industry, preferably in a sterile manufacturing environment with experience of protein and biochemical processing unit operations.
• Proven scale-up and technology transfer experience.
• Strong understanding of Process Engineering fundamentals with practical experience of designing pharmaceutical processes and utility systems to cGMP and regulatory requirements.
• Knowledge in the application of safety standards (e.g. PED, pressure relief assessment)
• Experience in developing process engineering site standards, process reliability and capability programmes desired
• Experience with documentation and practices in a regulated environment (e.g. GMP, FDA, MHRA)
Skills
• Strong leadership skills
• Excellent communication skills in both verbal and written forms and ability to describe complex process engineering matters to technical and non-technical people
• Proven skills in working/leading interdisciplinary teams to deliver projects, troubleshoot technical issues and implement effective permanent solutions
• Demonstrated attention to detail and organizational skills needed to successfully execute multiple activities and prioritize work load.

Please apply NOW for more information.

The candidate must have the rights to work in the location stated in the job advert.

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