A Process / Verification / Validation engineer position has become available with an innovative medical device business with operations in North Dublin. This is a global company with operations across the US and Europe. This role will work closely with both the R&D and manufacturing teams on their drug delivery platform.
- Engage in test method development and validation, with statistically significant acceptance criteria, test execution, anomalies resolution through hands on problem solving. Assists in development of verification methods to prove requirements across multiple system and subsystem levels.
- Providing Qualification and Validation support for process improvement, corrective work, and projects.
- Ensure data integrity, product and design traceability, clarity, and accuracy of quantitative evidence across all verification deliverables.
- Conceptualizes complete test solutions and coordinates execution of test campaigns that meets Quality & Regulatory expectations and internal development processes and procedures.
- Draft validation protocols and finalise reports.
- To provide information on relevant regulations and internal validation policy with regards to equipment/instrument, facility, utility, and process validations.
- To verify that validation studies once complete have been adequately recorded, documented, and carried out, in accordance with the approved validation plan and protocols.
- Actively promotes and participates in cross functional teamwork as an influential team member.
- The ideal candidate will be a Mechanical/Manufacturing/ Engineering graduate with 5 yrs. experience in a high-speed medical device operation within a highly regulated industry.
- Experienced in Test Method Validation (TMV) and risk analysis.
- In compliance with industry recognized standards and medical device regulations.
- A motivated and flexible person who can formulate detailed plans with minimum supervisory influence and manage them through to completion.
- Demonstrated strong communication and team-working skills including the ability to work effectively and influence decisions across functions, communicating effectively through verbal and written means.
- A track record of developing efficient, innovative, and creative solutions to complex and challenging engineering problems, using established tools and frameworks. Lean/Six sigma certification would be advantageous.
To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.