Validation Engineer

2 weeks ago

Sligo, Sligo, Ireland Headcount Solutions Full time

Headcount Solutions are seeking to recruit a QA VALIDATION ENGINEER for one of our leading multinational client sites in Sligo.

Responsibilities
  • Generation/maintenance/execution of the Site Validation Master Plan.
  • Generation/maintenance/execution of Project Validation Plans and schedules.
  • Generation of validation protocols and final reports to cGMP standards.
  • Generation of validation investigations and implementation of corrective actions.
  • Creation/Review/Approval of various quality documents and test data.
  • Management of validation, exception event, and change control processes.
  • Maintenance and tracking of validation equipment, if applicable.
  • Completing all required training before executing a task.
  • Documenting all activities in line with cGMP requirements.
  • Updating of validation procedures, job instructions and batch documentation to reflect current best practices.
Requirements
  • Qualification and/or degree in engineering or scientific discipline.
Experience Required
  • 3 years plus of knowledge of cGMP, validation and regulatory requirements relating to the biopharmaceutical industry.
  • Strong communication (written and oral), presentation and troubleshooting skills required.
  • Effective interpersonal and organizational skills.
  • Ability to work well both independently and in a team environment.
  • Capable of prioritizing work and multitasking.
Additional Requirements
  • This role is accountable for supporting a positive developmental culture with the organization while ensuring compliance with Quality policies.
  • Requires good knowledge of Company Policies and Procedures and involves working towards general results to achieve organizational needs.
  • May be required to support Cross functional teams and cost improvement projects.
  • Persuasion and direction skills required to convert thinking of others where gathering acceptance is difficult but important to job performance.
  • This position impacts manufacturing, product quality, and technical performance of the product produced at the site location.
  • Decision making within confines of agreed responsibility. Activities broadly defined by agreed goals and company competencies with general management oversight.
  • Close contact with Personnel within the plant at all levels.
  • Close contact with internal and external auditors, e.g. FDA, IMB.
  • Interaction with other site and TPM personnel in cross-functional activities.

For further information please forward your CV.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Management

Industries

Pharmaceutical Manufacturing

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