Description
Our Pharmaceutical client is looking for an experienced validation engineer to act as a client representative on their new start-up facility. The successful candidate will be the validation point of contact for specific onsite projects and provide support and expertise for validation of pharmaceutical equipment, facilities and/ or Utilities.Responsibilities:
* Strong experience in the facility and GMP utility commissioning and qualification.
* Strong experience in equipment commissioning qualification.
* Experience and participation in HPRA/ IMB audits.
* Experience operating in a Manufacturing or Operations environment.
* Understanding of Pharmaceutical Manufacturing Processes.
* Strong experience and working acknowledge of quality systems including Deviation and CAPA generation, investigation and resolution.
* Ability to assess impact of changes to direct and indirect systems during commissioning activities.
* Ability to co-ordinate and lead commissioning and qualification activities against project schedule and report to the validation lead and head of quality.
* Ability to resolve validation and qualification exceptions/deviations.
* Ability to liaise with cross functional teams and other contracting resources.
* Ability to direct and articulate quality requirements and represent the company in the achievement of compliant and qualified systems.
* Strong communication skills.