Senior Validation Engineer
REF #: SVC00016
Our client, Ireland’s leading medical device manufacturer, is looking for a Senior Validation Engineer for an initial 12 month contract.
The successful candidate will join a world class team of engineers that lead innovative healthcare projects. As pioneers in medical devices, this team are highly focused on elevating the standard of care – working to expand patient access, improve outcomes, reduce health system costs and drive value.
As a Senior Validation Engineer, you will be an integral part of this high performance team. You will be expected to apply industry knowledge and experience to deliver successful outcomes.
- Technical Writing:
- Advanced level of expertise required in regards to documenting newly designed processes and protocols.
- A fundamental understanding of the regulations that drive validations.
- Ability to write, execute and review validation documents to an extremely high standard.
- Instinctively understand the nuances between GxP vs Non-GxP requirements.
- An innate ability to decipher the differences between OQ & PQ processes.
- Process Validation:
- Be confidently familiar with the concept of process OQ (determining limit/challenge conditions).
- Ability to design, develop and execute expertly crafted OQ and PQ protocols and reports.
- Confidence and proven ability in the design and development of DOE & COV type experiments in order to:
- 1. Identify/Eliminate limit challenge condition
- 2. Identify/Eliminate key-inputs linked to key-outputs
- Formally trained and certified in Lean manufacturing, holding six-sigma green or black belt.
- A natural ability to professionally articulate process development and validation methodologies.
- As part of a high performance team, the ability to successfully influence key stakeholders should be second nature.
Education & Experience:
- BSc in Mechanical Engineering or related discipline
- Lean Six Sigma Green/Black Belt
- 5+ years validation engineering experience