Commisioning & Validation Engineer

Independent Solutions

Dublin

Job Title - Commissioing & Validation About Independent Solutions. Independent Solutions is a partner to leading clients in the pharma, biotechnology, medical sectors in Ireland and supports those clients achieve various results in a variety of roles. We have a large team supporting our clients onsite and offsite and this role will be based onsite in their facility. Duration of Role: This is a long-term contract role as part of Independent Solutions Service Level Agreement with this client. Estimated duration is 12-24 months. Job Duties: Description: Commissioning and Validation Engineer – Sterile Fill Finish. As a lead commissioning and validation engineer you will be responsible for working within a cross functional team to ensure that the validation activities associated with formulation, filling and inspection equipment and processes meets system requirements and recognised international standards. Major Responsibilities. • Development of Validation Plans and of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment. • Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training. • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards. • Prepare and execute validation protocols and complete risk assessments from a quality system perspective. • Assist with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), DQ. • Assist in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations. • Assist in deviation and exception resolution and root cause analysis. • Participate as required in project activities, including schedule and resource planning. Equipment in scope for project includes: • Vial filler of liquid and lyophilised vials. • Container closure integrity. • Visual inspection of finished vials. Experience/Background. • Equipment and Systems Qualification Experience up to and including PQ. • A third level qualification in Science, Engineering or a relevant Quality discipline. • Minimum 8 years’ experience in a similar role. Education Requirements. • A third level qualification in Science, Engineering or a relevant Quality discipline. Benefits of working with Independent Solutions. Excellent Team of Colleagues. Access to high-value projects. Excellent Technical Project Managers. Excellent pay & conditions. This job originally appeared on RecruitIreland.com.

2183 days ago