Engineering , Science, Pharmaceutical & Food

Equipment Engineer

  • Contract
  • Carlow, County Carlow, Ireland
  • 42006506

PE Global is currently recruiting a fully remote, Equipment Validation for a 6 month contract, with a leading multi-national Pharmaceutical client.

The role will support validation and qualification activities and will liaise with technical subject matter experts to ensure that equipment in use on site is validated and re-validated per global and local procedures and maintains compliance.

Duties of the role/Responsibilities

 

  • Responsible for helping to ensure that the validated equipment on site maintains validated status.
  • Act as quality support for validation and qualification activities of equipment, facilities and associated processes on site to ensure they are maintained in accordance with global and local procedures
  • Ensure that quality issues are identified, addressed and resolved in a timely manner
  • Responsible for supporting deviation close out and initiating/following up on corrective and preventative actions
  • Partner with colleagues cross functionally to provide support and advice on day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations etc

 

Education/Experience

  • Demonstrated ability in pharmaceutical equipment validation/qualification or quality support for same
  • Knowledge of EU/US quality related pharmaceutical regulations
  • Experience of Sterile manufacture preferred
  • Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in quality and/or engineering roles
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices requirements.
  • Knowledgeable in Industry Best Practices for quality and compliance related topics
  • Proven ability to effectively initiate and drive change
  • Strong verbal and written communication skills, project management skills
  • Report, standards, policy writing skills required
  • Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems)
  • Good Collaboration Skills
  • Ability to work as part of a team to determine priorities
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  • Demonstrated ability to drive the completion of tasks
  • Proven decision-making capability with accountability and responsibility

Interested candidates should submit an updated CV.

Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up-to-date CV to chloe.slingsby@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***