Associate Validation Engineer


Job Detail

Location Galway
Salary Negotiable
Role Type Permanent
Contact Emma Griffin

Associate Validation Engineer

Apply Now

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 0860334325/

Check out all our open jobs on our HERO Recruitment website – 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


Apply Now

Associate Validation Engineer

Emma Griffin

Role Type Permanent
Contact Emma Griffin
mobile +353 86 033 43 25
linkedIn profile click here

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