Associate Validation Engineer

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Emma Griffin
email quality@hero.ie

Associate Validation Engineer

Apply Now

Job ID: JOB-11979
Associate Validation Engineer



Background:



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 0860334325/quality@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval

Emma Griffin

JOB-11979

Apply Now

Associate Validation Engineer

Emma Griffin

Role Type Permanent
Contact Emma Griffin
email quality@hero.ie
mobile +353 86 033 43 25
linkedIn profile click here

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