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. 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:
1. Provide technical leadership for the acquisition and qualification of capital expenditure equipment and systems.
2. Project management input and contribution to achievement of project milestones.
3. Implementation of pharmaceutical and regulatory requirements for manufacturing processes and equipment.
4. Development and validation of manufacturing processes in support of business development and IP via proprietary processes or techniques.
5. Support 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 specifications, conducting supplier selection, managing relationships 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/processes 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 seek better engineering solutions to ensure the company has a competitive edge with standardised yet adaptable equipment/systems for process development and manufacturing.
* Conduct risk analysis of processes including prioritisation and implementation of mitigations.
* Create resource plans and costings for customer proposals.
* Communicate reports and presentations.
* Work collaboratively with Business Development and other technical colleagues, providing support relating to proposal/project development and direct customer engagement.
#J-18808-Ljbffr