LSC have a great contract opportunity for a Project Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Accountable for meeting key project deliverables for safety, financial management, schedule management and scope management across these projects. Accountable for ensuring projects are compliant with good engineering practices, company policies, regulations and codes. Liaise with Global Engineering/Global EHS/Global Procurement to ensure all are aligned and support project deliverables. Accountable for strict adherence to project stage-gate principles for managing the life-cycle of projects. Concept and Business Case development in collaboration with project Sponsor and End user, working with the end user to understand and clarify end user requirements, develop scope, cost and budget estimates and present to governance for approval Financial management - develop project budgets, obtain approvals for and adhere to project scope. Negotiate with contractors and suppliers to keep project within budget. Make cash flow projections. Make effective use of SAP and budgeting tools. ABOUT YOU - ARE YOUR SKILLS A MATCH? A degree in Chemical/Mechanical/Automation/Process Engineering with relevant experience in the pharmaceutical industry Minimum of 3 years project management experience across the project life cycle within a pharmaceutical environment. Demonstrable capacity to effectively manage and execute projects from initiation to completion: Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Cian Marnane on if you have any more questions about this role! Skills: Project Lifecyle. Budgeting Risk Management
LSC have a great contract opportunity for a QC Chemistry Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 2+ years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: * Plan and perform analyses with great efficiency and accuracy. * Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. * Report, evaluate, back-up/archive, trend and approve analytical data. * Troubleshoot, solve problems and communicate with stakeholders. * Initiate and/or implement changes in controlled documents. * Participate in audits, initiatives and projects that may be departmental or organizational in scope ABOUT YOU - ARE YOUR SKILLS A MATCH? * Bachelor's degree in a Science related field is required. * 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, * Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship. Thank you for your understanding. Apply via this advert or contact Sarina Abdulha on 0 if you have any more questions about this opportunity! Skills: Osmolality pH Clarity SOPs Routine testing
LSC have a great contract opportunity for a Project Engineer to join a leading Global Pharmaceutical company based in Cork. If you have 5+ years' experience in projects in the Pharma/Biotech industry and are ready for your next challenge, this could be the perfect role for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Delivery of projects from concept through to handover, including initiation, planning, design, execution, monitoring, controlling and closure. PE co-ordinates the Engineering Design, Construction, Commissioning and Qualification activities on EPCV projects varying in size and scope. Accountable for the generation of project scopes, estimates, schedules etc Co-ordinates activities of the engineering and design groups within the project team and identifies when specialist services may be required. Co-ordinate and direct the preparation of Project Controls data, i.e. Schedules, Budgets and Resourcing Plans for the Design and Constructions project Phases. Review progress and man-hour forecasts to enable corrective action decision making. ABOUT YOU - ARE YOUR SKILLS A MATCH? Degree in Mechanical, Electrical, Chemical or Process Engineering Minimum 5 years' experience in delivering capital projects in GMP environment Process background Ability to work cross functionally Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Cian Marnane at if you have anymore questions about this Project Manager opportunity! Skills: Project Management Budgeting Process Engineering
LSC have a great contract opportunity for a QA Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3+ years industrial experience and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials. Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File. Generates and maintains Product Specification Files (PSF) for IMP. Provides QA support and oversight of packaging and labeling operations for IMP. Support the generation and ongoing maintenance of Quality Agreements. Provides Quality Assurance support in the Use Date Extension process. Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics (EMEA and Asia) ABOUT YOU - ARE YOUR SKILLS A MATCH? A degree in science, engineering or related discipline is essential along with 3 years' experience in a role within the biopharmaceutical/pharmaceutical industry Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you. Apply via this advert or contact Sarina Abdulha on 0 if you have any more questions about this opportunity! Skills: GMP Batch SAP Veeva Batch release
LSC have a great contract opportunity for a Clean Utilities C&Q Engineer to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Development and execution of CQV testing documentation for Clean Utilities Responsible for meeting key project deliverables for safety, CQV schedule and quality of project related documentation/electronic records for equipment, utilities assigned. Responsible for ensuring GMP equipment and Clean Utilities are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations. Responsible for ensuring that all equipment, Utilities are tested in compliance with project related standards from a commissioning perspective. Deviation management associated with the assigned equipment and utilities. Risk Management - Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks. ABOUT YOU - ARE YOUR SKILLS A MATCH? The ideal candidate should hold a minimum of a BS qualification (Degree) in a scientific, technical or engineering discipline along with a minimum of 5 years of experience within the pharmaceutical industrial ideally with familiarity with Sterile Drug Product filling line experience. Specifically experience with CQ of High Purity Water systems, Purified Water & WFI Generation and Distribution systems. And Clean Steam and High Purity Gas Systems CQV project lifecycle experience from design through to C&Q and handover. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Cian Marnane on if you have any more questions about this role! Skills: C&Q Clean Utilities Project Management
LSC have a great contract opportunity for a Supply Chain Project Engineer to join a Cork based Biopharmaceutical company. The site manufactures low volume bulk API for Phase III clinical trials, initial product launch and long-term market support. The team on site grow, purify, formulate, and bulk fill mammalian cell culture derived APIs for medicines intended for human use. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Implementation of Supply Chain projects. Provide SCO input to site capital projects where required and attend meetings related to same where required Primary Warehouse representative at ORP's and projects to deliver strategic needs of the SCO group and site Perform E2E assessment for all new SCO related projects Own and implement effective Change Controls and Change Management Support teams technical development and project awareness ABOUT YOU - ARE YOUR SKILLS A MATCH? Minimum bachelor's degree in project management or related discipline. Supply Chain and Operational experience Audit experience desired. Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply! Apply via this advert or contact Cian Marnane at LSC on if you have any more questions about this role! Skills: Supply Chain Project Management Inventory Management
LSC has an exciting opportunity for a Supply Chain Planner to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. JOB PROFILE Supply Chain planning experience. Responsibilities for supply chain transactions related to purchasing product from CM's and close communications of status and change with internal and external stakeholders. Be part of Joint process Teams working with Contract Manufacturers Key Responsibilities: Use Lilly Supply Chain Standards, processes and and metrics to analyse supply chain performance related to customer service and inventory management. Establish an effective working relationship with supply chain personnel in each Lilly site that is supplied by relevant supply chains. Maintain an active network with other supply chain groups (e.g. Elexsa, DPEM, Global Supply Chain) Contribute to Supply Chain improvement projects and continuous improvements Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G with 14 months remaining or a Stamp 4 visa to apply! Call LSC on Siobhan Cummins at to discuss in detail or apply directly via this advert. Skills: Planning Supply Chain SAP
LSC have a great contract opportunity for Qualified Person to join a leading biotech company based in County Meath. Job Purpose This role will be part of our Quality Assurance Team in our state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland. What you will do: Perform Qualified Person (QP) duties in certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. Assure batch manufacturing and testing has been performed in accordance with cGMP and the relevant marketing authorization (MA) or clinical trial authorization, product specification file, legal obligations and/or technical agreement. Manage and/or escalate any potential CGMP and/or other concerns in a timely manner. Provide oversight of deviations (including approval of significant deviations) and laboratory investigations related to drug substance manufacture, testing and those that may present potential effect on product and /or material. Confirm change requests with product impact which require expanded review (e.g., regulatory, stability, testing impact) have been appropriately reviewed, approved and technically closed. Education and Experience: EU QP Qualification and experience (at least 5 years) of certifying batches for release in accordance with the relevant EC Directives including 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good Manufacturing Practice and Company Procedures. Expert level of knowledge of relevant GMPs, regulations and current industry trends. Communication, decision making, people influencing and project management skills. Problem-solving / critical thinking - ability to understand connections between different technical/quality system areas and recognize potential compliance issues. BSc. degree (or higher) in Biotechnology, Chemistry, Biology or in a relevant discipline. For our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship currently. Thank you for your understanding. Apply via this advert or contact Siobhan Cummins at if you have any more questions about this opportunity! Skills: qualified person Benefits: Work From Home
LSC have a great contract opportunity for a Quality Specialist to join a top pharmaceutical company based in Tipperary. The site supports the complete pharmaceutical small molecule process for Phase III clinical to product release and market support. On site processes include API manufacture, formulation, OSD tableting, packaging and global logistics & distribution. The facility takes in raw chemicals and ships finished medicines to end users. This site has grown from an API site to a strategically important campus that supports critical stages of the company's drug lifecycle. If you have a degree in Science or Quality and are ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification. Manage product recalls and stock recoveries as appropriate. Perform and review complaints and deviation investigations, change controls and CAPA's. Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements. Keeps abreast of cGMP requirements as described in applicable worldwide regulations. ABOUT YOU - ARE YOUR SKILLS A MATCH? Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations. Effective communications (oral/written) and interpersonal skills are necessary. The Specialist is required to possess a degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience. They must possess > 3years industrial experience Please note that for our contracting opportunities in the pharmaceutical sector in Ireland, candidates must possess either a Stamp 1G or a Stamp 4 visa. We regret that we are unable to provide visa sponsorship at this time. Thank you for your understanding. Apply via this advert or contact Grinne Hodnett on if you have any more questions about this opportunity! Skills: GMP Quality assurance compliance capa audits
LSC have a great contract opportunity for a Senior QA Specialist - Compliance to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 2+ years industrial experience and are ready for your next challenge, this could be the perfect project for you! Key Responsibilities: * Review and approve quality agreements. * Release incoming materials for use in manufacturing operations * Support qualification of new suppliers/materials and requalification of existing. * Assess supplier change notifications for impact to qualification status. * Support material certification and direct dispense programs. * Review and approve quality agreements. * Authoring, review and approval of QA-related procedures. * Support OpEx programs and champion continuous quality improvement initiatives. * QA review, assessment and approval activities for Biologics Manufacture, as applicable, for: o Change controls o Deviations/Investigations o CAPAs o Other associated documentation Qualifications & Experience BSc in Science or related discipline with a minimum of 2 years' Supplier Quality or related experience in a Biologics or Pharmaceutical environment. A clear understanding of cGMP requirements for QA systems and compliance and/or manufacturing. Detailed knowledge of Biologics Processing would be a distinct advantage. Required to work on his/her own initiative in addition to working as part of a team. Excellent communication, presentation, time-management and organizational skills are essential. Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level. Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please understand that we are unable to provide visa sponsorship. Thank you. Apply via this advert or contact Siobhan Cummins on 0 if you have any more questions about this opportunity! Skills: Compliance Supplier Quality
