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!
Project Document Controller Summary An experienced Document Controller is required as part of a 6-month contract due to a critical expansion project on site in Swords. The candidate will be required to have meticulous attention to detail, excellent communication skills, and the ability to work independently as well as cross functionally with a number of teams involved in the project. Although not limited to, the key responsibility of this position will be working with SME's to create and edit documentation for the expansion project and manage both the control and approval of the associated documents. Key Responsibilities Day-to-day responsibilities are focused on the control and tracking of documents. Specifically, you'll number documents and input technical revisions, perform compliance checking, filing and organizing, documentation auditing, and report on document status and distribute documents as required. Manage Operations/Operational Duties Frontline enforcement of approved document control procedures across the project organisation and interface with other project participants and team members Maintenance of the document database and associated project documents Undertakes periodic reconciliation of all batch records Prepares and issues logbooks to departments Review of SOP's, forms, etc for compliance with documentation templates Main contact for archival and retrieval for all GMP documentation for site Ensure completed GMP records are filed and archived as per procedures Writes procedures relevant to documentation management systems and document control. Administrative activities to support Regulatory requirements for provision of declarations and obtaining certs Manages information/Provide information Compiles monthly Periodic Review data for metrics and review at monthly Quality Council meetings Provides training on Document Management systems and procedures. Manages documentation trackers with respect to Batch Record issue and reconciliation Manage People/Interactions with People Liaise with all departments to ensure that documents are controlled consistently Provides training to staff from different functions on document management procedures as required Communicates document issues Communicates status of documents when requested Education/Experience Technical qualification in Science or Engineering or qualification appropriate to the position A minimum of 1 years-experience within a documentation management role of a pharmaceutical operation Experience with DCA/SAP/Trackwise preferred Working knowledge of GMP and compliance pertaining to GMP and EHS Excellent PC skills, MS Word, Excel, Powerpoint, Email and Calendar Proven ability to multi-task and work to tight deadlines Exposure or previous project management experience a distinct advantage Ability to consistently meet multiple and often conflicting deadlines. Strong written and verbal communication skills Self-starter and strong attention to detail and proven ability to produce results on strict deadlines If you are interested please click 'Apply' or contact Dominic on 01-645-5254 for further info.
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
Senior Automation Engineer SK biotek is seeking to recruit a Senior Automation Engineer on a contract basis. Reporting to the Automation Lead, key responsibilities of this role will include: Software/Hardware installation and configuration on PLC, SCADA, DCS and PI Historian systems Development and execution of automation design, commissioning and validation testing documentation Automation plant support, including, if deemed necessary, the provision of 24hr plant support Problem determination, recording and analysis of Automation problems, to help prevent reoccurrence Provision of training and support to appropriate personnel/departments in the early detection and resolution of issues Ensure successful delivery of automation projects and automation aspects of projects in order to meet business needs in a cost effective and efficient manner and in compliance with site standards and procedures. Developing and maintaining collaborative relationships with stakeholders. Implementation, control and maintenance of security access to automation systems, Implementation, management and maintenance of backup, archiving and restore of GMP data from automation systems Adherence to the GAMP 5 Guidelines and Computer System Validation Policy, internal, external audit requirements and company policies Contributing to the overall success of the department by working with fellow team members and other department groups to ensure that a quality automation support service and project service is provided. Required Qualifications and Skills: The ideal candidate will also have: Knowledge of SCADA / PLC, DCS networks and associated hardware & software, particularly DeltaV, and experience of working with and troubleshooting automation systems Knowledge of Windows / Microsoft Administration. Experience in Virtualisation is an advantage Good working knowledge of the Process Automation / I.T industry standards and frameworks A proven track record of compliance in a GMP environment Strong interpersonal, organisational and communication skills The ability to consistently meet deadlines. Interested applicants can click 'Apply' or call Dominic on 01-6455254 for further info.
Principal Analytical Development Scientist A Principal Analytical Development Scientist 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 play a critical and leading role in the establishment of the In-Process analytics team in the Process Sciences department. He/She will be responsible for developing and delivering transformative analytical solutions to compliment the pioneering science performed in the department. The ideal candidate will apply cutting edge analytical technology to provide directional data for in-process samples in a rapid and reliable manner in a non-GMP environment. 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 industries. Key Responsibilities Applying an excellent knowledge of latest industry trends you will be responsible for developing/optimizing in-process analytical methods to provide quick and reliable directional data to support complex investigations and laboratory studies within the process sciences department. Implementation of automated and high-throughput analytical methods to assess product quality attributes of mAbs will be a priority for the position. Previous experience in such technologies is highly desirable. Create/Review/Approve new test methods and assays. Ensure robust and timely sample management procedures are implemented and maintained. Establish and maintain an excellent working knowledge of industry trends and developments in the analytics space. Liaise with other analytical groups internally to ensure best practice is followed. Lead technical troubleshooting and laboratory investigations. Develop and deliver training programs for PS analysts. As a principal analytical development scientist, you will be central in growing and developing the new in-process analytics group. Position requires very strong technical skills in combination with excellent communication capability. You will be expected to clearly and effective liaise with senior department management on a regular basis. Education/Experience Requires Ph.D in Analytics, Chemistry, Biology or related field, with 5+ years of relevant experience. Requires MSc in Analytics, Biochemistry, Chemistry, Biology or related field, with 9+ years of relevant experience. Interested? Call Jack on 01-6455250 for more information or click apply below!