Senior Process Development Engineer

Senior Process Development Engineer - Pharmaceutical - Cambridgeshire – Permanent Overview: Our client is a leading pharmaceutical development and manufacturing organisation at the cutting edge of the industry. At present, they are seeking a Senior Process Development Engineer to join their engineering group on a permanent basis at their facility in Cambridgeshire. They are looking for suitable candidates to; * Provide technical leadership for the acquisition and qualification of capital expenditure equipment and systems. * Project management input and contribution to achievement of project milestones. * Implementation of pharmaceutical and regulatory requirements for manufacturing processes and equipment. * Development and validation of manufacturing processes in support for business development and IP generation via proprietary processes or techniques. * Supporting Manufacturing teams with technical troubleshooting of Fill Finish Processes. Experience: * Engineering experience in a GMP environment. * Degree qualified, preferably Chemical Engineering or related subjects * Specification, selection, and installation of CAPEX equipment. * Ability to write technical documents including knowledge of regulations and best practices within pharmaceutical manufacturing. * Validation activities including specification writing, qualification testing and reporting * Knowledge and/or experience of drug product handling & filling operations for drug delivery devices * Knowledge of manufacturing process design, scaling, and characterisation * Knowledge of QbD, DoE and statistical process control methodologies. * Experience working under the GMP and ISO13485 quality systems * Experience in risk assessments and risk management * Aseptic and sterile experience Responsibilities: * Lead technical projects including generation of specifications, conducting supplier selection, managing the relationship with suppliers during the build phase, and performing commissioning activities. * Support commissioning and qualification activities of manufacturing equipment, facilities, and utilities including authoring and execution of validation protocols. * Work with process development and manufacturing functions to translate developed formulations/process’ to final clinical products. * Perform design feasibility for customer devices and provide engineering solutions to enable technical transfer into the facility whilst ensuring future scalability. * Provide technical support to the Device Development team to ensure device platforms are compatible with fill-finish systems. * Keep up to date with market trends and look for better engineering solutions to ensure the company has a competitive edge when it comes to standardised yet adaptable equipment/systems for process development and manufacturing. * Risk analysis of processes including prioritisation and implementation of mitigations * Creation of resource plans and costings for customer proposals. * Generation and communication of reports and presentations * To work collaboratively with Business Development and other technical colleagues, providing support relating to proposal / project development and direct customer