Automation Infrastructure Engineer Summary An Automation Infrastructure Engineer (software) is required to join a leading biotechnology manufacturing company. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations. The individual will be responsible for delivering and maintaining automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused manufacturing of Biopharmaceuticals. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry. Key Responsibilities Responsible for overseeing and maintaining automation-based systems and solutions which provide for flexible, innovative, cost effective, compliant and quality-focused environment. The automation systems include; Supervisory Control and data acquisition (FactoryTalk View) Site Historian System (including OSIsoft PI & GE historian) Advanced Analytical applications Asset management systems Thin Client Server systems 2012 & 2016 Server Operating systems Process Area Networks SQL Databases Supports the validation of automation systems with QA Validation. Provide automation technical knowledge for troubleshooting, investigations and training. Provide automation system application support including installation. Provide automation system design for data integrity, stability and interface between different systems. Ensure effective maintenance and availability of automation equipment. Optimization and compliance: Responsible for technical optimization of the automation systems. Creation, modification, and maintenance of automation system and documentation, including automation specification documents and SOPs, in a compliant state. Education/Experience Degree in preferably computer Science, Chemical, Mechanical, or Electrical Engineering, from an accredited university or college with 0-2 years relevant experience. Preferred Knowledge and understanding of the following: Experience with cGMP and validation pertaining to biopharmaceutical production operations and computerized systems is highly desirable. Networking: Cisco Switches, Firewalls Process Control System Administration: Rockwell FactoryTalk View and AssetCentre, ThinManager Historical Data System Administration: GE Proficy, FactoryTalk, OSI PI, Yokogawa Design, configuration, programming, and qualification of: Rockwell FactoryTalk Systems, ThinManager; GE Proficy SCADA and Historian Please note - Stamp 4 or EU required. Interested? Call Jack on 01-6455250 for more information or click apply below!
QA Manager A QA Manager is required to join a leading Pharmaceutical company based in North Dublin. This position offers an impressive and unique opportunity for interested candidates and requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations. This role will be responsible for providing compliance leadership ensuring the site operates to the applicable cGMP and international standards for their customers on a daily basis, as well as a number of critical responsibilities across the site. This is a great opportunity to join a select team that has quickly established itself leading the way in the Pharmaceutical industry in Ireland. Reporting Structure - Quality Director Key Responsibilities Manage quality aspects of GMP computerized systems and the supporting infrastructure used on site to ensure compliance with company policies, procedures and regulatory expectations. Mentor and coach a highly skilled, professional team to ensure that validation activities are completed in line with cGMP and international standards. Review and approve the GMP design aspects of major capital projects including new facility construction, facilities upgrade, new manufacturing equipment and support systems. Ensure that all Equipment and Computer Systems are validated to the required cGMP standards and are maintained in a validated status. Coordinate and participate in review and approval of change controls, SOPs, reports and other documentation, review and approval of master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria Support customer and regulatory inspections Drive the development and implementation of new techniques, systems and initiatives to enhance the quality system on site. Champion continuous improvement with particular focus on right first time and lean methodologies Develop and deliver training with regard to compliance based on business needs. Manage key elements of the quality management system including document management process, internal audit process and change control process Partner with QA Operations team to ensure that in promoting a culture of Compliance, Right First Time and Continuous Improvement. Education A minimum of a Bachelor's Degree in Science, Engineering or similar technical discipline. Advanced qualifications are desirable and at least 10 years' experience in the Pharmaceutical industry. Core Competencies Strong Quality and People Management skills Strong understanding of the key business drivers of the industry/organization. Excellent communication and organisational skills with demonstrated expertise in effectively communicating with all levels of the organisation are required. Candidates should be able to demonstrate an ability to lead cross-functional teams and to make decisions in pressurised situations to ensure compliance. Interested? For more information on this, and other suitable roles, please contact Jack on 01-6455250, or email your CV to jack.conway-kenny AT experis.ie
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.
Associate Manager - MES Operations Summary The Associate MES Manager is responsible for the management of the Manufacturing Execution Systems on site, the integrity of the data housed therein and the associated data exchanges - an exciting time to be involved in a number of key MES projects on site. This role is also responsible for ensuring that MES fully meets the needs of the business by aligning with Clinical and Commercial leadership and that associated policies and processes are effectively implemented and maintained. This role provides leadership, support and guidance to the MES support team to ensure that the business' needs are met with daily support and maintenance. Key Responsibilities Coordinate the needs of functional groups and establish the priorities for MES requirements, system design and implementation and assign appropriate project to group. Conduct requirement and design session with users as needed for continuous process improvement Review company documentation including SOPs, requirements and Manufacturing Batch Records to assess MES impact Develop strong business relationships with Clinical and Commercial groups to attain a solid understanding of their goals and objectives for better support with MES capabilities. Develop strong business relationships with Quality Assurance and Material Management for an understanding of their goals and objectives for alignment with MES capabilities Develop a strong business relationship with Information Technology to cultivate a solid understanding of roles and responsibilities with MES implementation and maintenance Align MES Support team's business practices with Clinical and Commercial objectives to pro-actively anticipate future needs and create solutions to address them Assume responsibility for maintenance including all future upgrades, enhancements and validations as needed and approved by senior management. Work with system vendor to guarantee MES is up to date and can easily meet current and future business needs. Actively drive process improvement initiatives as appropriate. Provide system performance and usage metrics as required. Collaborate with appropriate Training groups to develop and schedule training sessions that best serve the business needs Provide MES team members with guidance and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals. Support multiple instances of MES throughout the IOPS organization Review and approve MES Change Controls Ensure GxP compliance Respond to audit inquiries Education/Experience BA/BS in engineering, biological or physical science, computer science, or information technology required. A minimum of 6 years of relevant experience including 2 years of experience working with MES or manufacturing systems within a life science manufacturing environment MES system configuration experience Experience in programming automation systems (DCS) and SQL preferred Key Competencies Familiarity with technologies used throughout MES Process (i.e. Interfaces, Level 2, Integration and Infrastructure), MES recipe configuration, MES workflow, SQL, Oracle and relational database concepts Knowledge of Werum PAS|X Knowledge of integration of MES systems with ERP and Shop Floor systems Interested? Call Jack on 01-6455250 for more information or click apply below!