Engineering Specialist

1 week ago


Carlow, Ireland Claran Consultants Ltd Full time

Job Description

We are seeking a highly skilled GMP Validation Professional to join our team at Claran Consultants Ltd. This is an exciting opportunity for candidates interested in a new challenge in a GMP regulatory environment.

The successful candidate will support several aspects of validation, including design/author/review/approve/execute qualification/validation documentation and cycle development studies, execution/development of change controls, and technical input into quality notifications.

Key Responsibilities:

  • Support the development and implementation of validation strategies and protocols.
  • Conduct qualification and validation activities, including design, author, review, approve, and execute qualification/validation documentation and cycle development studies.
  • Lead cross-functional teams to resolve technical issues and improve process efficiency.
  • Develop and implement change control procedures to ensure compliance with cGMP regulations.
  • Collaborate with production, maintenance, and quality teams to ensure seamless execution of cycle development and performance qualification activities.
  • Provide technical input into quality notifications, including authoring, reviewing, and approving investigations.
  • Perform root cause analysis of system failures and develop corrective actions to prevent reoccurrence.
  • Serve as a subject matter expert on validation-related topics and represent the validation team at global technical forums.

Requirements:

  • 5+ years of experience in a GMP validation role, with a strong background in pharmaceutical or biotechnology manufacturing.
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Demonstrable experience of leading technical-related projects.
  • Knowledge of CTU equipment qualification, thermal mapping equipment, and thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Ability to analyze and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications required.

About Us

Claran Consultants Ltd is a leading consulting firm providing expert services in GMP validation, compliance, and process improvement. We are committed to delivering excellence and supporting our clients in achieving their goals.



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