Systems Engineer

Recruiter
Experis Ltd
Location
Cambridge
Posted
12 Jul 2018
Closes
11 Aug 2018
Contract Type
Permanent
Hours
Full Time
Systems Engineer

Cambridge

12 Month Initial Contract

Up to £500 per day





ROLE SUMMARY

You will be part of the Packaging & Delivery Systems group within Global Technology Services and be responsible for marketed combination product Design History File build and enhancements for on-market products. You will ensure the design controls are documented in accordance with internal procedures. Successful candidate MUST have Pharmaceutical experience.





ROLE RESPONSIBILITIES
  • Responsible for generation, approval and storage of all Pfizer device design control documentation for assigned device projects
  • Ensure effective design control activities at external design companies for assigned projects
  • Responsible for generation, approval and storage of all Pfizer device risk management documentation for assigned device projects
  • Ensure effective risk management activities at external design companies and all manufacturing facilities related to assigned projects
  • Responsible for generation, approval and storage of all Pfizer device human factors engineering documentation for assigned device projects
  • Responsible for generation, approval and storage of all Pfizer device manufacturing control strategy documentation for assigned device projects
  • Provide input and support to human factors usability studies for assigned device projects
  • Provide input to purchase specifications for devices and device components
  • Ensure effective device design change control, ensuring that quality and regulatory requirements are satisfied
  • Work as part of a multidisciplinary team to determine what performance factors of the device are critical to the compliance of the finished product
  • Work with Quality Assurance to ensure appropriate quality agreements and purchasing controls with vendors/suppliers
  • Work with regulatory to provide all required documentation for regulatory submissions for assigned device projects




Essential Attributes

Education
  • Engineering Degree, or equivalent in relevant subject.


Experience
  • Background of working in teams in the development, operational or trouble shooting of equipment, devices or manufacturing processes by means of designed experiments and logical problem solving.




Technical ability
  • Thorough theoretical knowledge and understanding of degree subject


Presentation
  • Able to anticipate what information is required by their colleagues and to disseminate it actively and efficiently.


To apply please send you CV's in the first instance.
This job was originally posted as www.cwjobs.co.uk/job/82302488

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