Test Engineer
Location: Cambridge
Contract: 12 month contract
Rate: up to £25 per hour
A multinational Pharmaceutical company is looking for a Test Engineer to join their team on a 12 month basis.
The role:
1. Works as part of a multidisciplinary team to determine what performance factors of the drug delivery device will require assessment and investigation.
2. Supports interactions with external vendors and internal partners within activities such as design verification, shelf life studies, shipping studies, and manufacturing process qualification for drug delivery devices.
3. Assists in the preparation of regulatory submissions and internal/external audits.
4. Applies statistical, scientific, and engineering expertise and research experience to solve problems creatively and independently and support decision making.
5. Applies method development and method validation principles to the qualification and use of bespoke test equipment.
6. Uses analytical and statistical tools to analyze the data in order to quantify the functional performance characteristics of the drug delivery device.
7. Able to define appropriate approaches to quantify design parameters, including design of experiments and statistical interpretation of data.
8. Performs other duties as assigned in support of business goals (e.g., hands-on testing).
Requirements:
Essential Attributes:
1. Degree, HND, or equivalent in a relevant Science or bioengineering subject.
Experience:
Essential Attributes:
1. Previous experience of working with device design control system life cycle and drug delivery device testing.
2. Working experience of test method development and validation.
3. Good knowledge of mechanical and/or electronic testing of drug delivery devices.
4. Experience of working in teams in the development or troubleshooting of drug delivery devices, analytical methodology, or manufacturing processes.
5. Preferred deep knowledge and application of guidance and standards such as ISO 11608, ISO 13485, ISO 14971, IEC 60601, ASTM 4149, and GMP/GLP.
Technical Ability:
Essential Attributes:
1. Good standard of written and spoken English and numeracy.
2. Previous experience within the drug delivery medical device or Pharmaceutical industry.
3. Logical and intuitive thinker.
4. Able to communicate with others outside team/group.
5. Able to learn and apply established procedures in a reliable and consistent manner.
6. Evidence of productivity, speed, and quality.
7. Able to communicate to a team, in an appropriate oral and/or written format, the outcome of any investigations.
Desirable Attributes:
1. Literature searching and distillation and application of findings (where appropriate).
Circumstances:
1. Able to travel or relocate to Cambridge area.
2. Flexible attitude to working hours if the job demands this from time to time.
3. Positive attitude to animal experimentation.
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