UK Cambridge Operations Scientist - Medical Devices, Electro-Chemistry, Six Sigma

Job Title:               Operations Scientist - Medical Devices

Key skills:             Electro-Chemistry, Six Sigma, Medical Devices

Location:               Cambridge

Duration:               Permanent

My client is developing a range of Distributed Clinical Diagnostics Systems and is looking for an Operations Scientist to be responsible for providing scientific and operational support to the operations group.

Key Responsibilities.
1.      To undertake operations activities as assigned by the Operations Manager.
2.      To gather analyse and report operational data.
3.      To undertake transfer and scale-up activities form R&D.
4.      To conduct, analyse and report validation programs.
5.      To generate operations documentation.
6.      Working with QA to process map and identify CTQ's for operational processes.
7.      To develop control plans for operational processes.
8.      To identify and implement improvements to operational processes.
9.      Ensuring that all assigned key project tasks and milestones are met. Where this does not occur to develop and implement action plans to correct and prevent future occurrence.
10.     To undertake identify and document CAPPA processes.
11.     Ensure that all work is carried out in line with company health and safety procedures and policies.
12.     Maintaining all written documentation according to company standards.
13.     To ensure that all work is carried out to the defined regulatory standards (cGMP's and ISO 13485 2003).

Qualifications
A minimum of degree qualification or equivalent in Electro-Chemistry, Biochemistry, or another appropriate chemical / biological science. A six sigma qualification is highly desirable.

Experience
Typically a minimum of 4 years experience in either Diagnostics or Biosensor production. Some supervisory experience would prove advantageous.

Key Skills and attributes
1. Highly developed analytical skills including design of experiments and hypothesis testing.
2. Very practical and able to work with minimal supervision.
3. Strong communication skills.
4. Detailed understanding of the requirements of cGMP and ISO 9001 as applied to the manufacturing environment.
5. Objective and data driven.
6. Functions well in short time scale environments.
7. Innovative in approach to problems.
8. Good knowledge of current “lean” philosophy and practice.

General
The person should be willing to re-locate to the Cambridge area.
The candidate must be flexible as some international travel will be required (primarily to the US).

Please email a word version of your cv quoting Ref. No. 7b01d and call any time +44 (0)20 8224 9006

Ref: 7b01d