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