Validation Engineer

HERO

Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Aisling Kidney
email careers@hero.ie

Validation Engineer

Apply Now

Job ID: JOB-13052
Validation Engineer

Purpose

An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments.

Responsibilities

  • Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning.
  • Manage the validation requirements of third party suppliers and CMO’s.
  • Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation).
  • To maintain and take responsibility for the cleaning validation strategy
  • To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU.
  • Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
  • Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams.
  • Establishing, implementing and directing validation and revalidation activities.
  • Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
  • Reviewing and managing Change Control Forms for Validation implications.
  • Reviewing and managing Non-Conformance’s for Validation Implications.
  • Updating existing quality documentation related to validation activities.
  • Identifying training requirements in support of validation.
  • Ensuring completion of validation protocols.
  • Carry out Internal Audits as required.
  • Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
  • Maintaining validation documentation system.
  • Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
  • Assisting in the preparation and hosting of associated regulatory and customer audits.

Experience

  • Minimum Bachelor of Science or Engineering.
  • 4-5 years’ experience in a pharmaceutical environment.
  • Good computer skills with Word, Excel and any other statistical programs.
  • Knowledge of Process and Cleaning Validation.
  • Ability to conduct internal audits.
  • Ability to perform in external audits

For further information on this role in Galway please contact Aisling Kidney on 0872197421 or careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Aisling Kidney

JOB-13052

Apply Now

Validation Engineer

Aisling Kidney

Role Type Permanent
Contact Aisling Kidney
email careers@hero.ie
mobile +353 0872197421
linkedIn profile click here

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