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Senior Process Development Engineer

Adepto Technical Recruitment Ltd
Posted 11 days ago, valid for 7 days
Location

Landbeach, Cambridgeshire CB25 9FD, England

Salary

£55000 - £70000/annum Plus Benefits

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Contract type

Full Time

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Sonic Summary

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  • The Senior Development Engineer position is with a leading pharmaceutical development and manufacturing organization located in Cambridgeshire, offering a permanent role.
  • Candidates should have a minimum of 5 years of engineering experience in a GMP environment, with a degree in Engineering or a related field.
  • The role involves providing technical leadership, project management, and ensuring compliance with pharmaceutical regulations and manufacturing processes.
  • The salary for this position is competitive, reflecting the candidate's experience and expertise in the field.
  • Ideal candidates will have experience in CAPEX equipment specification, validation activities, and knowledge of QbD and statistical process control methodologies.

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

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