Description
A key client of mine are looking for a bright, engaging, delivery-focused Product/Validation Engineer to come in and help them on an contract basis.Based in the picturesque South West, this contract will pay £40 per hour and be an initial 6 months - if you impress and both parties are happy, there is scope for extension.
The primary purpose of the role is taking product / process from R&D into manufacturing also responsible for writing and executing IQ, OQ, PQ protocols.
The right candidate will have proven technical and engineering knowledge with working knowledge of medium to high volume manufacturing processes - manual and automatic.
More than anything, the client want someone who can be versatile, adaptable, 'hit the ground running,' and deliver expectations.
Key skills/experiences:
- Assists in the process validation aspects of medical device / Life Sciences product development.
- Experience generating and executing protocols that challenge the critical processing parameters for engineering studies, process validations, design validation, etc. Execute URS, FAT/SAT, IQ, OQ and PQ
- Design, run, and gather data for experiments. Statistically analyze and document test results in formal reports and laboratory notebook as necessary.
- Generate documentation such as manufacturing, test and inspection procedures (MP, TP, QP, etc.). Responsible for processing Engineering Change Orders and Development Change Orders
- Participate in the design of new test methods, equipment, and procedures.
- A minimum five years product development experience in a medical device or Life Sciences manufacturing environment. Demonstrated experience with process validation protocols and testing.
- Practical experience of conducting Risk Assessments via pFMEA and dFMEA
- Working knowledge of tooling and manufacturing processes
- Advanced computer skills including MS Office applications (Word/Excel) and Minitab statistical analysis software are required.
If you know of anyone who may be interested we offer vouchers up to £200 for a referral that results in a placement.
Thanks and kind regards,
Nathan Puxty