Bioassay Specialist This Bioassay Senior role is a critically important activity to ensure efficient and effective compliant design, construction, qualification, and operation of a new strategic facility. This tremendous opportunity will be responsible for qualifying the Bioassay analytical lab and the transfer of Bioassay analytical methods. Additional development opportunities within the micro and chemistry lab will be strongly considered to recognize the tremendous value of knowledge / experience gained by the candidate during the project phases. To maximize the development opportunity, the candidate will be the key leading talent in analytical Bioassay techniques and developing the flow of testing through the lab, to ensure the lab will be best in class across our industry, a benchmark for others to aspire to. The candidate will support the complete analytical lab build. The facility will utilize the latest innovations in technology and automation and latest in analytical techniques. Together, the team will build the future of biologics through a Quality culture that delivers unconstrained supply, Right First Time to our patients through an inspired team. The full analytical scope will incorporate micro, chemistry, bioassay, raw materials, stability and in-process). Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in analytical transfer and qualification of methods. Key Responsibilities Perform activities for general lab readiness, laboratory equipment qualification and method transfers. Strong knowledge and experience of Bioassay methods. Perform and carry out a variety of analytical techniques including but not limited to Potency Elisa test in compliance with GMP requirements. Follow up-to-date analytical practices with reference specifications, regulations and industry standards. Plan and maintain the laboratory testing schedule to achieve an efficient QC system. Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures. Ensure training is current for all job functions performed. Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations. Delivery of area performance to meet or exceed performance or quality goals. Promote and participate the implementation and maintenance of the relevant safety programmes. Participate and Comply with Quality Management System requirements. Responsible for driving a culture of Continuous Improvement by deploying Six Sigma tools. Assist in the "operationalising" of the lab with a strong focus on MPS. Train and help develop other analyst within the lab. The candidate will be actively supported and encouraged to continue their development and knowledge build, incorporating areas to support their future development and ability to continuously improve in their current role. Qualifications Degree qualification (Science/Quality/Technical). Master preferred. Desirable evidence of Continuous Professional Development. Preference Lean Six Sigma Key Experience 3-5 years industry experience with significant knowledge and experience in working in a Bioassay lab unit and working with contract labs Experience in Potency Elisa method Working knowledge of QC Systems (EN, LIMS) and Trackwise Interested? Call Jack on 01-6455250 for more information or click apply below!
Summary The Senior System Integration Specialist is responsible for the overall system integration design, implementation and support for a system or group of systems within the IOPS technology landscape. Key Responsibilities Provide hands-on delivery of integrating different systems. This includes developing code, reviewing business requirements, authoring technical documents, designing processes and procedures Promote best practices in design and development of applications and integrating systems Give guidance on technologies and/or methodologies that could meet solution design needs Provides hands on end-user support for assigned application integrations including troubleshooting problems across the system level Logs support incidents and prepares appropriate resolution plans. Performs administration activities such as setting user accounts, roles, access, and privileges. Researches integration problems and issues and prepares appropriate resolution plan. Performs changes in development, validation or equivalent testing environment, and production environments. Identifies and resolves system defects and system engineering level deficiencies. Responsible for documentation, including converting user requirement specifications to a detail design specification, writing configuration test plans, test scripts, and summary reports. Processes appropriate system change control requests. Education/Experience BA/BS in Information Technology or related field with 5+ years relevant experience. Experience in a Pharmaceutical, Biotech, Medical Devices or Research environment with knowledge of GMP, 21 CFR Part 11 and Annex 11 desired Hands on experience with Oracle Fusion or other applicable middleware or integration platforms preferred Experience with Oracle 12c, 11g databases, PL/SQL programming Experience with Web Services preferred Knowledge and understanding of Weblogic Application Server, JMS and J2EE architecture, technology and concepts Knowledge of cloud integration platforms Knowledge in developing SOA Composites involving RESTful/SOAP APIs with XML, XSLT, JSON Standards Knowledge on building ADF, ADF-DI user interfaces preferred Key Competencies Demonstrated ability to interpret and document an extensive variety of business and technical processes. Requires knowledge of the computerized system development life cycle. A demonstrated ability in creation of requirements, design documents and test scripts. Must be competent to work at the highest technical level of all phases of system design and implementation. Must show strong judgment and time management skills. Ability to anticipate client needs and propose alternative business solutions. PLEASE NOTE: Candidates must have full working rights in Ireland i.e. a current Stamp 4 Visa or an EU Passport to be eligible to work in Ireland to be considered for the role. For more information or to apply to the role contact Emmet on 01 6455250 or email to emmet.mceneaney AT experis.ie.
On-Site Technician - Level 2 IT Support Role Purpose In this role you will provide technical support as part of the service delivery provision. You will be a part of Window 10 upgrade project and work with the installation, troubleshooting, problem resolution and maintenance of this project. You will respond to questions regarding operation and malfunctions and advise on preventative maintenance and configuration adjustments to improve product performance. Required Skillset Experience with Windows 10 and proving Deskside support Good communication skills Ability to work with minimal supervision Ability to take ownership of complex problems For more information on this or other roles feel free to contact Alison on 01 6455250 or alison.byrne @ experis.ie