Job Title: Validation Engineer
This is a permanent, full-time position for a Validation Engineer at a global medical devices company based in North Wicklow/South Dublin.
Key Responsibilities:
* Develop and execute validation protocols to ensure compliance with regulatory requirements.
* Compile and review validation summary reports to identify trends and areas for improvement.
* Conduct data analysis, including statistical interpretation and sample size calculations.
* Validate software systems and ensure they meet regulatory standards.
* Review and update validation documentation to reflect changes in regulations and procedures.
* Collaborate with the maintenance and engineering team to ensure calibration activities are completed on-site.
Requirements:
* Minimum 3 years of experience in a pharmaceutical or medical device manufacturing environment.
* Bachelor's degree in a science or engineering-related field (preferred).
* Knowledge of validation documents, including VMP, FAT, SAT, IQ, OQ, and PQ.
* Understanding of production operations, GMP, and GLP requirements.
* Strong organizational and administrative skills, with attention to detail and a desire for excellence.
* Ability to work effectively in a team environment, prioritizing tasks and managing multiple responsibilities.
Preferred Skills:
* Familiarity with equipment, instrumentation, and software, including incubators, freezers, filling lines, freeze drying processing equipment, and validation software.
* Proficiency in Microsoft Office, particularly Word, Excel, and PowerPoint.
* Statistical software knowledge and experience with computerized systems validation.
Personal Qualities:
* Excellent communication and interpersonal skills, with the ability to present information effectively.
* Strong problem-solving and troubleshooting skills, with a willingness to collaborate and influence others.
* Continuous Improvement mindset, with demonstrated achievements from previous roles.
* Ability to read, analyze, and interpret technical data, as well as prepare presentations and respond to questions in a group setting.
Language Skills: Fluency in English, both written and oral, is required.