Associate Validation Engineer
Job ID: JOB-11979
Associate Validation Engineer
Reporting to the Snr Validations Engineer the Validation Engineer (Associate) will be responsible for scheduling and executing validations/qualifications per Standard Operating Procedures (SOPs), protocols and regulatory guidelines for manufacturing process systems and software validation projects, while report writing, summarizing results and conclusions.
Major Roles & Responsibilities:
This role will involve reasonability for the following;
- Coordinates and communicates all testing with affected functional groups and evaluates test results.
- Participate in improvements and development to the validation program as needed to remain current with cGMPs and industry standards.
- Participates on teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
- Write validation plans, reports and procedures.
- Assist Manufacturing Engineering and Automation Engineering in designing, documenting, performing and improving process validations. Ensure validation program meets requirements of ISO13485, PMDA where appropriate.
- Execute manual tests for software and system validation. Carefully analyse and document test results.
- Assist software system developers and subject matter experts in designing, documenting, performing and improving verification tests. Ensure validation program meets requirements of FDA (21CFR11), ISO, PMDA and GAMP 5 where appropriate.
- Provide early stage consultation to other departments on computer system validation requirements at the project proposal stage.
Knowledge and Skills Required:
- Excellent working knowledge of Microsoft Office Packages including Word, Outlook, Excel etc.
- Knowledge of Minitab and statistics.
- Ability to manage multiple projects with competing schedules.
- Knowledge of ERP, database systems, PLC programming methodologies and systems.
- Knowledge or GAMP5, FDA (21CFR11), ISO, PDMA.
- Knowledge and working application of validation principles, guideline and industry practice, risk assessments, CAPA, change control.
- Excellent interpersonal & communication skills in English (business language), both written & verbal.
- An active listener who clearly and effectively shares information & successfully communicates key messages.
Qualification and Education requirements:
- Requires a Level 8 or higher degree in an engineering or science discipline.
- Minimum of 2-3 years of related experience (medical device/pharma preferred).
- Experience in medical device/pharma industry in the development and deployment of quality systems, process controls and continuous improvement systems.
For further information on this role in Galway please contact Emma Griffin on email@example.com
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