Description This position is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures as required by GMP. Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. Duties and Responsibilities Is an active member of the QC group and participates in the following key activities. QC Material Release & Scheduling Activities. QC Key Performance Indicators. QC Training Personal competency & Team development QC Documentation Review & Approval Site Cross Functional Teams Comply with EHS rules and procedures. Delivers on the department Goals & Objectives & Continuous Improvement initiatives. Support relevant internal and external site audits as required. Maintains and develops knowledge of analytical methods, technology, and compliance demands. Foster a culture of quality, safety, and compliance across the Site in line with the J&J Credo Key Skills and Competencies Required: Builds strong productive relationships. Demonstrates ability to work with teams and individuals. Holds self-accountable for compliant and flawless execution. Clear communication skills. Innovative. Always demonstrate Integrity and Credo-based actions Education and Experience: Third level Degree in a science or pharmaceutical discipline. A minimum of 3 years experience in a quality or compliance role within the pharmaceutical industry. Skills: Microbiology 5 years GMP EHS Material Release
Position Summary Responsible for delivery of quality assurance activities at the Dublin location to ensure New products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements. The Quality Assurance Specialist executes the site QA activities in order to protect the safety, quality, and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the companys business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services, Engineering and Planning to optimize patient supply. Principal Responsibilities Quality Oversight on new product introduction in Bulk Drug Substance facility. Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to the manufacturing Facility. Review and Approve project documents involving cross-functional, multi-departmental teams including Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others. Review and approval of validation documents for equipment, software and equipment qualifications, and others. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures. Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, process validation, and cleaning validation documents. Review and Approve TRAs, MSRs, SAP requests related to new products. Ensure all Materials are sampled and released as per the approved specifications and procedures. Investigation and approval of deviations generated encountered during qualification/validation testing. Participation in the project change control program and deviations for modifications to new and existing equipment. Provide guidance to project teams on Quality regulations for Validation strategy and approach. Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk. Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups. Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain, and material movement. Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives. Actively support audit readiness activities and regulatory agency and internal audits. Qualifications A minimum of 5 years relevant experience within the pharma industry or a related field. Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required. Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable. Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA, or other authorities of similar standing. Excellent accuracy and attention to detail Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar Planning and organizing skills are required to plan, execute, and track commitments of Quality Assurance and to adjust to changing priorities. High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management. Technical writing skills required. Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written. The individual in this position is expected to represent the companies Pharmaceutical interests, objectives, and policies in a responsible and professional manner. Education Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years experience in cGMP Quality environment; or equivalent combination of education and experience. Skills: GMP FDA Bulk Drug SAP
Position Summary: We have a great opportunity for a MSAT Engineer to join our MSAT Validation team. The MSAT Engineer will be responsible for the following. Active engagement with the MSAT team, delivering a successful outcome to all MSAT validation activities using Good Manufacturing Practices (GMP). Primary activities are in the Cleaning Validation area. Planning, documenting and performing cleaning validation studies. Leading and/or providing technical guidance for cleaning/ process improvement projects and investigations. Leading and/or providing technical guidance for process improvement projects and investigations. Secondary activities include, but are not limited to Thermal Validation, Process support Validation, Supporting process improvement projects, Supporting New product Introduction/ process validation, GMP documentation generation (e.g. protocols / SOPs / WIs / Technical Documents, Exception/Event Investigations). Main Duties and Responsibilities: Conduct MSAT activities in compliance with US and EU regulations, procedures and EHS&S requirements. Develop MSAT documentation (e.g. strategies, plans, protocols, procedures, reports) and co-ordinate MSAT document review and approval. Review and approve documents prepared by other MSAT colleagues. Field execution of MSAT protocols. Liaise with Manufacturing to provide support where required with routine operations / project-based work. Compile relevant information from contractors, suppliers, and other departments to develop technical reports. Representing the MSAT site team on platform technical teams. Initiate and implement change control activities in accordance with site procedures. Track and resolve exceptions/events/deviations during MSAT activities. Prioritize MSAT activities in line with Manufacturing / project schedules. Co-ordinate MSAT activities with contractors and vendors as required. Attend identified training, required to fulfil the role of a MSAT Engineer. Participate in multi-functional teams (project, investigations) as required. Key Skills and Proficiencies Required: Excellent interpersonal skills. Ability to operate as part of a team is essential. Proven leadership skills and critical thinking ability. Excellent communication skills both written and verbal. Attention to detail. Innovative with great problem-solving skills. Results and performance driven. Adaptable and flexible. Integrity, trustworthiness and objectivity. Knowledgeable of FDA/EMEA regulatory requirements. Education and Experience: Required: A minimum of a Degree in Engineering, Molecular Biology, Biochemistry, Pharmacy or related scientific field is required. At least 2 yrs experience in the Large Molecule manufacturing industry or equivalent. Focus on patients and customers at all times. Desirable: Experience in Cleaning validation studies and Cleaning strategy (Minimum 2 years). Also, beneficial would be experience in Thermal Validation, Process Validation, Supporting process improvement projects, Supporting New product Introduction. Ability to interact at different levels of the organization, perform under pressure and handle conflicting interests. Ability to work independently under general direction, having a good sense of prioritization of goals and good time management. Ability to lead multi-functional team and to manage complexity and change. Proven knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. Skills: Chemical Engineer Cleaning Validation Thermal Validation Process Validation Protocols SOP
Process Support Specialist required for a leading Biotech facility, in Carlow, initially an 11 month contract. Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customers. ROLE: Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system. Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements. Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system. Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team. Required to comply with Client Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Assist in the management and/or assignment of IPT training if required REQUIREMENTS Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline At least 3 years t experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting Skills: Biotech Process Support CAPA's Pharmaceutical
Process Engineer to provide technical process design support for Bioprocess systems on new Process Area CAPEX project. Essential Duties and Responsibilities include, but are not limited to, the following: Generation User Requirement Specification (URS) for assigned systems. Reviews and approves Basis of Design (BOD) and detail design of assigned systems i.e. PFDs, P&IDs, etc. Ensures procurement packages (bill of materials (BOM), datasheets, cutsheets etc) meet equipment specifications. Tracks HAZOP action items and ensures action items are incorporated into system design. Attends 30%, 60% and 90% model reviews ensuring systems meet operational, safety and ergonomic requirements. Reviews and approves system lifecycle documentation (FS. SDS, IO lists, etc) and ensures they meet requirements. Attends factory acceptance test (FAT) of associated equipment if required. Attends automation software bench FAT if required. Supervises and executes Site Acceptance Testing (SAT) and commissioning activities. Generates FAT, SAT and commissioning protocols for assigned equipment and ensures protocols meet specifications. Ensures Vendor Document Requirements (VDR) meet requirements. Builds Preventative Maintenance (PM) tasks and spare parts lists on Computerised Maintenance Management System (CMMS) Education and experience: Requires BS/BEng in Chemical, Process or Mechanical engineering with 3 - 5 years related experience. Direct experience with biopharmaceutical process equipment is preferred. May substitute relevant experience for education. Experience with design and commissioning within biopharmaceutical sector would be desirable. Experience with DeltaV would be desirable Skills: BOD HAZOP FAT CMMS VDR SAT
Description: The position requires effective cross-functional collaboration with external and internal partners including External and Internal Technical Services, Manufacturing Science & Technology (MS&T), Product Development and Clinical Supply (PDCS), Supply Relationship Management, External Manufacturing and Operations, Quality and Regulatory partners. You will be responsible for: Developing and implementing TT Strategy including Process Validation, Control Strategy. This includes drug substance and drug product (biologic). Leading technical gap assessment & ensuring implementation of any associated mitigation activities. Authoring and reviewing project related documentation including process validation and comparability documentation. Reviewing approving supporting protocols and reports. Ensuring site specific Cleaning Validation and Media Fill Strategy is aligned with global requirements. Provide SME input to technical aspects of Regulatory filing and IR response. Providing support to Regulatory audits as needed. Support the implementation of TT and Validation best practices across the network, work closely with other members of the ATO TT and Validation team on implementation of improvements. You will need to have: 6 years experience providing technology transfer project support to drug substance or drug product manufacturing. Proven ability to successfully manage Tech transfer programs at site level and corporate level in support of GMP operations. Comprehensive understanding of Technical/cGMP requirements for Tech Transfer activities. Ability to present and defend tech transfer topics during regulatory agency inspections. Experience of biopharmaceutical Bulk Drug Substance (BDS) manufacturing and aseptic fill finish. Extensive knowledge of regulations, current industry practices, and experience of interpretation and application of guidelines and regulations. We would prefer for you to have: Bachelors degree in Science or Engineering, (or related field). Organized analytical thinker with strong attention to detail. Excellent oral and written communication skills, including technical writing. Ability to communicate technical and regulatory drivers with the proven capability of implementing TT projects. Skills: MS&T Process Validation Drug Substance Drug Product
The Quality Specialist role: Participate as functional expert in the cross functional team that manages production right first time at site. Review and approve batch, cleaning, and testing documentation. Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed, and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives. Provide detailed knowledge of quality systems in place and ensure that root cause is identified and corrective actions as appropriate are completed. Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments. Provide feedback on re-occurring issues ensuring continuous improvement to systems/processes. Ensure changes controls raised are documented, assessed, and completed. Prepare Annual Process and System Reviews. Act as lead/team auditor to support the internal GMP walkdown and scheduled audits. Participate in the generation and communication of quality metrics. Creation, review, and approval of quality procedures as required. What skills you will need: In order to excel in this role, you will more than likely have: Degree or post-graduate qualification in Science, Pharmacy, or equivalent. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise). Knowledge and demonstrated expertise in Lean / Continuous Improvement. Experience and knowledge of GMP Requirements for Electronic /paper free operations. Experience in High potency manufacturing desirable. Communications: Excellent written and oral communication skills. Organizes and delivers information appropriately. Teamwork: Interacts with people effectively. Able and willing to share and receive information. Decision Making: Uses sound judgement to make good decisions based on information gathered and analysed. Adaptability: Adapts to changing work environments, work priorities, organizational needs, and diverse people. Work Standard: Sets and maintains high performance standards. Pays close attention to detail, accuracy, and completeness. Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self-direction. Skills: SAP Trackwise Laboratory Out of Specification CAPA
Senior Technical Specialist / Drug Substance required to provide technical support to drug substance projects / technical developments across various CMOs / External Manufacture. Competent in broad functional capabilities and acts independently in their role. Initially a 2 year contract Providing technical and scientific direction for ongoing commercial drug substance manufacture at CMOs. Provide technical direction for the identification and implementation of process optimization initiatives as well as efficiency and capacity improvements at CMOs, using AI tools where applicable. Provide significant technical depth to support continuous process improvement to maximize yield and lower cost of goods (CoGs). Partner with regulatory and quality assurance colleagues to ensure that processes are maintained in a validated and compliant state throughout their lifecycle. Oversee process monitoring and statistical analysis of commercial external manufacturing activities (continued process verification). Support the generation and review of CMC sections of the NDA/MAA and other technical documents for regulatory agency submission for commercial CMO sites. Communicate operational status of CMOs regularly to management, as required, at the appropriate level of detail. Communication will be both written documents, and in formal and informal oral presentations. Up to 20% of international travel may be required for this role. Requirements: Minimum of 5 years experience in a technical or manufacturing role in the pharmaceutical industry with a major focus on drug substance (DS). High level of technical expertise in DS pharmaceutical manufacturing across multiple processing areas. Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing. Broad experience of technology transfer, process validation management, and continuous improvement. Effective communication skills to enable successful relationships with both internal and external stakeholders. Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections. Minimum undergraduate degree in scientific discipline (Biochemistry, Chemistry, Pharmacy), Engineering (Chemical, Mechanical) or related field. Experience with AI and AI related tools for Continuous improvement projects is desirable. Skills: Drug substance manufacture
Summary The Manager, ET BU Marketing, PKU will play a pivotal role in shaping and executing the HCP engagement and contents for the PKU franchise, a rare genetic condition that severely affects how a person can think, feel and eat. Reporting to the ET BU PKU Marketing Lead, this individual will serve as the project lead for various marketing initiatives, overseeing the end-to-end projects management from conception to evaluation of performance. This will require a tight alignment with the cross-functional and -country commercial teams and vendors to ensure project outcomes meet the pre-defined goals in terms of quality and uptake, timeline and budget. The initiatives encompass various customer engagements, multi-channel content development and dissemination plans in line with the overall brand strategy and messaging objectives. The key collaborating functions include Medical Affairs, Marketing in local affiliates, Compliance, Digital Strategy and Operations, Congress Management, Corporate Communications and Patient Affairs. This role requires strong sense of urgency, ownership and problem-solving mindset, backed by demonstrable skills in communication, multi-tasking and teamwork. The ideal candidate will bring experience in biotech/pharma marketing and passion for improving patient outcomes in rare disease. Responsibilities Customer Strategy and Engagement: Lead the design and implementation of prioritised PKU customer engagement activities at medical congresses, advisory boards, advocacy events. Coordinate with cross-functional and -country teams to design optimal messaging, speaker panel, innovative delivery formats and drive uptake. Build and maintain relationships with opinion leaders, advocacy groups, and key customers to identify business opportunities and champion the voice of customers for future engagements. Collaborate with countries to develop or align on strategy and frameworks pertaining to customer segmentation and prioritization, and integration into local sales. Content Generation: Lead or support generation or adaptation of contents for HCPs and Patient/Caregivers/Patient Advocacy Groups that are resonant with customers, aligned with brand strategy and messaging objectives. Provide guidance to country teams for localization. Multi-channel Strategy and Operation: Collaborate closely with Digital partners and affiliate marketing teams to plan, develop and disseminate prioritised contents across personal and non-personal channels. Identify opportunities for quick wins in external paid/earned channels and ongoing maintenance and optimization of owned channels like websites. Participate in the enterprise-wide digital transformation to facilitate uptake across the organization and represent the brand. Project Performance Monitoring: Develop and manage project vendor, budget, outcome quality and timelines and performance against goals. Set measure of success, collect, analyse, and report on engagement and impact metrics, providing actionable insights for ongoing improvement. Brand Strategy and Operation Support: Support ET BU PKU Marketing Lead on various business review and planning meetings and communications that facilitate business growth, brand positioning and collaboration. Maintain file repository and communications on MS TEAMS. Compliance and Risk Management: Work with the Compliance team to ensure projects adhere to pharmaceutical regulations, company policies, and ethical standards. Anticipate potential compliance risks, plan mitigation and clear roadblocks with the promotional reviewers throughout the project lifecycle, ensuring proactive mitigation strategies and timely resolutions. Education and Experience A relevant bachelors degree such as Life Sciences, Communications or Business Administration Fluent in oral and written English, an additional European language advantageous About 5 years of experience in the biopharmaceutical industry, with a preference for background in marketing, demonstrating a successful track record in cross-functional project management Demonstrable exposure to international, multiple brands and scientific fluency will be highly valued Strong collaborative skills, with the ability to engage effectively with stakeholders at various levels of the organization to cultivate productive working relationships Proven ability to coordinate multiple projects and deliver high-quality results in complex markets and therapeutic areas Excellent communication skills, both verbal and written, with the ability to convey information clearly and effectively Adaptable and agile in response to change and new knowledge areas Sense of urgency, ownership and problem-solving mindset Strategic Thinking and Results-Driven: Capable of formulating strategic plans with a clear focus on achieving measurable results Skills: Brand Strategy Project Performance Monitoring Digital Strategy and Operations Corporate Communications and Patient Affairs.
Treasury Manager - 6 Month contract. Dublin location. Remote working is available for candidates based elsewhere in Ireland. Responsibilities: Manage EMEA cash management activities, including daily cash positioning and intercompany funding, with a focus on continuous improvement Prepare cash flow forecasts and related analysis using bank, ERP, and other financial systems Maintain bank accounts, including opening/closing of accounts and updating signatories Support the issuance, administration, and ongoing management of letters of credit and bank guarantees Support the integration of newly acquired business from a treasury perspective Develop, monitor, and maintain relevant treasury KPIs to support effective performance and decision-making Oversee intercompany balances and assist with their timely settlement Support regulatory compliance such as KYC and AML Develop, maintain, and enhance treasury procedures to ensure efficiency and compliance Assist in optimising the ERP system for treasury processes Provide advice, guidance and hands-on support on treasury operations to other functions Perform ad-hoc Treasury analysis and projects Required Skills: 5+ years of experience in multi-national Corporate Treasury department Solid understanding of treasury operations, particularly cash forecasting, bank account management, with knowledge of corporate banking practices Strong IT capability, particularly advanced Excel skills for data analysis and reporting Experience working with treasury workstations, ERP systems, and various bank portals Strong work ethic, attention to details, ability and willingness to work effectively independently as well as part of a team Excellent communication and organizational skills Experience managing multiple projects simultaneously Working knowledge of SAP is an advantage Education: University degree in Business, Accounting or Finance Treasury Qualification (ACT/CTP) is a plus Skills: Multi-national Corporate Treasury department
