Senior Development Engineer

Senior 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 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 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