Job Summary:
In this role, you will be handling routine Lab activities as part of applicable project requirements in West. You will take part in Lab test handling, including reviewing the obtained results, the establishment of a new testing procedure in the Lab, defining testing protocols and generating reports/summaries. As part of this role, you will be able to work with different testing Equipment types, handling with calibration requirements and working with consumables, drug products and other goods. This is a hybrid role, based in Dublin Ireland.
Essential Duties and Responsibilities:
- Handling Lab Test Requests – write, review, and approve.
- Writing Lab testing protocols, summary, and reports
- Write/update and review Lab procedures.
- Test Method Validation (TMV) – planning, writing and execution.
- Design Validation Testing (DVT) - planning, writing and execution.
- Investigation and approval of Out of Specification (OOS)
- Support external Lab testing and work with Laboratory Information Management Systems (LIMS)
- Lab Equipment Owner and Calibration Coordinator (per calibration procedure)
- Compliance to all local site Environmental, Health and Safety regulations.
- Compliance to all local site company policies, procedures and corporate policies.
- Other duties as assigned.
Basic Qualifications:
- Education- B.sc in Mechanical / Bio Medical Engineering, or equivalent
- Experience: Working in a Medical Device company – advantage.
Preferred Knowledge, Skills, and Abilities:
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
- Ability to be proactive, consider the wider network and is forward thinking.
- Excellent written and verbal communication skills.
- Excellent attention to detail
- Ability to use own initiative to problem solve and to further enhance own skills.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.