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 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