Purpose In this role you will provide strategic business partner support to the site across global support functions. You will have opportunities to support a range of assignments across the Ireland HR Network including but not limited to policy development and Compensation/Benefits. Responsibilities Provide Strategic BP support across client groups in driving & realising their people strategy. Support delivery of annual performance and talent processes as well as succession planning; provide coaching and feedback on how to improve individual performance to meet business objectives. Proactively manage employee relations to ensure a highly effective workforce capable of achieving business goals. Industrial Relations; model and champion effective partnership with our unions. Support and coach the business to ensure successful management of issues. Lead union partnership with one of our three union groups. Represent the company during dispute resolution processes. Work collaboratively across site and as part of the Irish HR network to provide support in implementing various projects as required. Develop, implement and update local and country HR policies and support communication of same. Work collaboratively with management to provide advice and guidance on compensation and benefits and assist with salary and bonus administration. Lead critical updates to people managers and SLT at monthly forums. Provide SME knowledge to ensure seamless delivery of T&A function (Kronos) of HR. Provide ad hoc administrative support including compliant management of department purchase orders. Skills required 2-3 years' experience in an HR role, ideally working in a large multi-national environment. Bachelor's degree; CIPD qualification or relevant master's degree. Industrial Relations skills and previous experience partnering directly with union groups is essential. Ability to build partnerships and to work effectively with people at all levels. Highly effective communicator with the ability to influence outcomes at all levels of the business. Ability to project manage multiple projects and initiatives through to successful delivery. Good knowledge of Irish and European employment law framework. High level of independence and initiative while working effectively as part of the team. Seniority level Mid-Senior level Employment type Contract Job function Human Resources Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
A recruitment agency in Cork is seeking a mid-senior level HR professional to provide strategic business partner support, particularly in managing employee relations and union partnerships. The ideal candidate will have at least 2-3 years of HR experience in a large multinational setting, as well as a Bachelor's degree and preferably a CIPD qualification. Strong communication and project management skills are essential to succeed in this role that involves developing HR policies and supporting performance processes. #J-18808-Ljbffr
A leading recruitment agency is looking for a Compliance Engineer to support compliance activities in a biotech facility in Dunboyne, Ireland. The role requires a thorough knowledge of compliance standards in pharmaceutical manufacturing and at least 2 years of experience in CSV activities. Ideal candidates will have strong collaboration and communication skills, with a focus on maintaining the highest quality and compliance standards. This contract position offers a salary range between €39,474 and €79,618. #J-18808-Ljbffr
Purpose The Compliance Engineer will be responsible for supporting DMO Compliance activities at the single use multi-product biotech facility. Responsibilities Ensure permanent inspection readiness within the DMO team. Support generation, review, and approval of CSA deliverables. Provide ongoing compliance (GxP, Financial, Data Privacy) coaching and support to all team members. Manage deployment of Global SDLC/CSA and IT Security policies and procedures. Ensure supply of all compliance components required to deliver high quality product through tactical planning and execution of project and compliance deliverables, including change‑control, periodic reviews, performance monitoring, system administration, access administration, disaster recovery, deviations, incident problem management/investigations, CAPAs, audits, policy deployment, cyber security, data integrity, EHS, training, etc. Ensure highest Quality, EHS & Compliance standards. Active participation in the Tier process and proactively resolve issues. Liaise with Compliance Engineers from other areas and support Site Quality Council and other site quality initiatives. Coordinate AIT Change‑controls, EHS activities and EHS/Quality metrics. Complete AIT Investigations, root‑cause analysis and CAPAs. Strong project management skills to support project delivery and operational readiness. At least 2 years experience in planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant. A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11 and 21 CFR Part 11. Strong knowledge in Data Integrity (MHRA Data Integrity Definitions and Guidance for Industry and PIC/S Guidance Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments). Experience in PLC/SCADA/DCS systems. Requirements Preference for Lean Six Sigma Green Belt. Desirable to have qualification in Project Management and Computer Validation. Very strong collaboration, compliance and communication skills. Desired Skills and Experience 2+ years CSV experience in biologics manufacturing. Knowledge of EU GMP Annex 11, 21 CFR Part 11, Data Integrity. Experience with PLC/SCADA/DCS systems. Degree in Science/Engineering. Strong project & compliance management skills. Seniority level Mid‑Senior level Employment type Contract Job function Manufacturing Industry Pharmaceutical Manufacturing Location Dunboyne, County Meath, Ireland Salary: €39,474.00‑€79,618.00 #J-18808-Ljbffr
A leading recruitment firm in Dublin is looking for a Process Development Specialist to support new product introductions and lifecycle changes for syringe products. The ideal candidate will have a Bachelor's in Science or Engineering with at least 5 years of relevant experience in drug product processing. Responsibilities include leading regulatory filings and providing technical expertise for product formulation and validation. This role offers a contract position with competitive compensation. #J-18808-Ljbffr
Base pay range Purpose: This role will require the candidate to provide process development support to new product introductions (NPI), technology transfer, lifecycle changes to syringe products, provide subject matter expertise for product formulation, filling and characterisation to support production. The candidate will provide technical support to large molecule and small molecule drug product manufacturing at site as well as part of the global Process Development (PD) organization. Responsibilities Leads new product introductions and lifecycle changes into SF01, SF02 and SF03 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer. Be a key contributor to regulatory filings as part of the NPI process throughout the authoring, editing and submission process but also be responsible for response to regulator questions as and when required. Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling syringes/devices, inspection, and transportation for parenteral products through the NPI or post-NPI phases. Provide process development expertise for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing. Develops and characterizes drug product processes and transfers technology to commercial drug product sites. Identifies and implements operational opportunities for current and new sterile operations. Troubleshoots issues with drug product processing technologies and equipment. Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA. Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management. Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert. Development of validation plans, process performance qualifications (PPQs) for syringe filling. Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards). Participate and lead in validation cross functional teams at the site to ensure adherence to required policies and procedures. Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations. Input to site validation guidance documents. Collate and report on relevant shipping and filter validation. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. Contribute to product quality assessments and process flow documents. Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process. Lead or assist in deviation and exception resolution and root cause analysis. Participate as required in project activities and be developing own project management techniques. Requirements A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience. Knowledge of cGMPs and other worldwide regulatory requirements. Problem solving ability and excellent oral and written communications skills. PhD or Masters in Science or Engineering. 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation. Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze‑thawing, filtration, mixing, filling, and/or lyophilization processes. Knowledge of protein biochemistry regarding chemical and physical stability. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Desired Skills and Experience 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation. Acts as a drug product manufacturing technical expert to provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling syringes/devices, inspection, and transportation for parenteral products through the NPI or post-NPI phases. Seniority level Mid‑Senior level Employment type Contract Job function Manufacturing Industries: Manufacturing #J-18808-Ljbffr
Senior Project Manager - Manufacturing Support The Senior Project Manager - Manufacturing Support is responsible for a broad variety of project management activities that support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations. Purpose The role will help plan, coordinate and deliver New Product Introductions (NPIs), deviation lifecycle development, operational and strategic projects (including capital, reliability and process‑improvement / volume initiatives). Embedded in Manufacturing Support, the post will partner closely with Direct Manufacturing, Process & Aseptic Owners, Quality, Engineering, Validation, MES, Technical Writing and other site and global stakeholders to establish safe, compliant and sustainable project management that maintain supply continuity. Responsibilities Support both Direct Manufacturing and Manufacturing Support across vial and syringe drug-product (DP) and finished drug-product (FDP) operations. Project manage timelines associated with complex investigations (deviations, aseptic excursions, batch issues, equipment failures) owning timelines, meeting scheduling, communications and lifecycle visualisations / tracking. Maintain daily/weekly project momentum with clear project controls, ensuring on‑site presence and hands‑on leadership of cross‑functional teams. Lead and facilitate project meetings and governance forums to accurately capture and track actions, timelines, deliverables, milestones and decision‑points; clarify and document roles and responsibilities and ensure timely closure and verification of action owners' commitments. Provide timely escalation of project risks and issues and make decisions that enable progress within the contract timeline. Effectively communicate with everyone involved in the project. Have a controlled scope in place that is understood by all stakeholders and maintained throughout completion of the project. Maintain actions/risk and decision logs. Work with resource managers across the organisation to effectively obtain and allocate resources to complete programs and projects on time. Define and align project objectives with Direct Manufacturing customers and site leadership; create and maintain comprehensive project plans that address quality, scope, cost, schedule, resources and manufacturing readiness. Project manage medium to large technical projects (capital, reliability, NPI, lifecycle) from concept through design reviews, build, validation readiness and handover to operations. Qualifications and Experience Technical degree and/or Masters or equivalent. 5‑8 years of experience (including a minimum of 3 years as a Project Manager) in a Life Science / Pharmaceutical / Biotechnology environment. Preferred Experience Portfolio management, portfolio resource management, business case development. Preferred Qualifications PMP or PRINCE2 certification. Experience with Lean Six Sigma methodologies. Knowledge of industry‑specific regulations and standards. Systems / Equipment Smartsheet, MS Office, MS Project, MS PowerPoint and MS Visio. Trackwise Change Control & Document Management Systems. Seniority Level Mid‑Senior level Employment Type Contract Job Function Project Management Industries Pharmaceutical Manufacturing #J-18808-Ljbffr
A leading recruitment agency is seeking a Senior Project Manager for Manufacturing Support in Dublin. The role involves coordinating and delivering New Product Introductions and managing complex project timelines in a pharmaceutical manufacturing environment. Candidates should have 5-8 years of relevant experience, including project management expertise in life sciences. This is a contract position at a mid-senior level. #J-18808-Ljbffr
