Commissioning And Validation Engineer

Independent Solutions

Dublin South

Job Title. Commissioning and Validation Engineer. About Independent Solutions. Independent Solutions is a partner to leading clients in the pharma, bio, 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 the Amgenfacility in Dublin. 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. Minimum Requirements Candidates must haves = experience in GMP environment (strictly min 3 years), experience in equipment qualification, ideally experience with performing vendor FAT, SAT and on-site qualification and integration. Job Description As a commissioning and validation engineer you will be responsible for working within a cross functional team to ensure that the validation activities associated with process equipment for vial and syringe fill finish processes meets system requirements and recognised international standards. Major Responsibilities • Assist in development of Validation Plans and development 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 can 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. 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 5 years experience in a similar role. Education Requirements • A third level qualification in Science, Engineering or a relevant Quality discipline. Skills & Experience Proven Biotech experience in the given area, as follows; B.Sc or B.Eng or related qualification. Experience in Document Preparation and Execution. Experience in major start-ups where clean-into-service, coverage testing, baseline studies in commissioning area, and cleaning validation studies may be concurrent activities in different trains. Good technical knowledge of BioTech equipment and the concepts of BioTech manufacturing. 3-5 years Biotech cleaning validation experience ideal (1-3 years experience may also be considered for similar roles with this and other clients. Have Troubleshooting and analytical mindset. Organised with ability to delivery results in professional manner. Enthusiastic and possess Positive Attitude & Mindset. Excellent Interpersonal Skills. 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.

2185 days ago