Description
Excellent new opportunity for a Quality Engineer to work for a Global Biotech organisation based at their facility in Ireland.Responsibilities:
-Developing validation documentation such as validation summary reports, configuration and specification documentation, calibration operation procedures and design processes.
-Provide support for calibration, repair, installation, troubleshooting, and documentation of equipment used in the analytical labs. All work to be completed to assure minimal impact to production while complying with cGMP and Client regulations.
-Ensure that calibration paperwork, instrument files and work order documentation is completed with accurate information.
-Participate in a detailed training program in order to develop one`s knowledge in the instrumentation field and other areas of the plant.
-Assist in the development, revision, and updating of related SOPs for work related areas.
-Basic troubleshooting and repair of laboratory instruments. Perform regular certification of equipment to verify conformance to industry standards and Client procedures.
-Plan and schedule own work activities with Lab staff to minimize impact to production activities.
-Involvement in projects as part of continuous process improvement and / or troubleshooting
-Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s
-Contribute and assists with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits
-Other functions that may be assigned.
Competencies/Skills:
-Science/Engineering degree and 2 years` experience in Validation/Chemistry/Engineering/Microbiology gained within a biotech, pharma or health care organisation.
-Ability to effectively communicate ideas through verbal and written form. Intermediate computer skills
-Ability to interact constructively with peers/teams.
-Experience with CMMS, Cerity, Empower would be advantageous