Description
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 troubleshooting 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 your CV's in the first instance.