LSC have a great contract opportunity for a Project Engineer to join a Kerry based Biopharmaceutical company. If you have 5+ years of experience working in the pharmaceutical or biotechnology industry ,then please reach out. This might be the ideal role for you! RESPONSIBILITIES: Lead the delivery of Engineering projects on time, on budget & in accordance with all project & business Safety & Quality goals. Scope new Engineering projects & secure Capital approval Lead, support and participate in commissioning and qualification activities both current and future projects. Updating & influencing management and project stakeholders. Coordination of the participation of specialist trades and specialist departments Coordination of project interfaces with other projects and departments EDUCATION/EXPERIENCE: A BEng or BSc degree is preferred 5 years minimum delivering engineering projects in an bio pharmaceutical manufacturing facility Proven ability to handle and prioritize multiple tasks. Apply via this advert or contact Cian Marnane at LSC on if you have any more questions about this role! Skills: Fill Finish Aseptic Manufacturing Full Project Lifecycle
LSC have a great contract opportunity for a Senior Cleaning Validation Lead to join a biopharmaceutical company in Dublin focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. If you have 10 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: To provide cleaning expertise in Upstream and Downstream equipment: including parts washers, media vessels, bioreactors, centrifuge, depth filtration/clarification skids, buffer vessels, purification equipment including chromatography, ultrafiltration, viral filtration skids, downstream vessels and supporting process equipment. To author and review cleaning related documentation, gap assessments, technical protocols and reports, and cleaning validation documentation, strategy documents. Defend cleaning validation strategies and studies during regulatory inspections. Provide SME leadership to a team of specialists to ensure delivery of project milestones. To identify requirements for laboratory studies to support cleaning decisions, and to liaise closely with 3rd party Laboratories/Process Development / Procurement / MSAT to oversee the design and execution of cleaning studies. To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines. To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scale. ABOUT YOU - ARE YOUR SKILLS A MATCH? Minimum undergraduate degree in chemistry, biology, engineering or related discipline. Minimum of 10 years' experience in a pharmaceutical manufacturing organization, with expertise in Bulk Drug Substance manufacturing, with previous experience in Cleaning Validation of cell culture unit operations and/or downstream unit operations. Previous experience of cleaning cycle development or cleaning cycle improvement in a technical role is advantageous. Proven expertise in leadership including demonstrated ability to drive for results and lead innovation and change. Comprehensive understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant. 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 Kathy Gillen at LSC on if you have any more questions about this role! Skills: Senior Cleaning Validation Validation Pharmaceuticals Manufacturing Upstream Downstream
LSC have a great contract opportunity for a Project Manager 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: Lead and support the delivery of GMP Lab Systems projects across the full project lifecycle-from initiation and scoping through execution, commissioning, qualification, and closeout. This role will focus on projects relating to laboratory systems, instrumentation, data management platforms, and enabling IT/AIT components within a regulated GMP environment. These projects will span GMP benchtop test equipment, analytical technology upgrades, and supporting utility or facility modifications where required. The successful candidate will work closely with stakeholders across Quality Control, Quality Assurance, IT(AIT), Validation, and Engineering. They will also have regular interaction with senior leadership as they deliver projects that underpin the site's laboratory capability and ensure our QC operations remain compliant, efficient, and future-ready. ABOUT YOU - ARE YOUR SKILLS A MATCH? A degree in an engineering discipline preferred. Minimum of 5-7 years project engineer/manager experience across the project life cycle within a pharmaceutical environment Biologic Manufacturing site experience 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 Management Full Project Lifecylce Budget Management
LSC has an exciting opportunity for a Supply Chain Associate - Customer Service to join a pharmaceutical company in Cork. Overview: The role is a hybrid of supply chain and project management, focusing on managing relationships with contract manufacturers (CMOs) Key responsibilities: Setting up supply chain processes between new suppliers and the client Master data management using various tools including SAP Reconciling inventory Organizing shipments Experience with SAP and strong attention to detail are essential Education & Requirements: Level 8 degree Additional qualifications in Procurement, Supply Chain, or Logistics (IIPMM, IPICS, APICS) are advantageous. Minimum of 5 years' experience in Supply Chain, Customer Service, Logistics, Compliance, or Operations. Strong computer skills, particularly SAP or similar systems, and MS Office (especially Excel). Preferred Experience in pharma contract Experience in multinational organisations. 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! Call Siobhan Cummins LSC on to discuss in detail or apply directly via this advert. Benefits: Work From Home
LSC have a great opportunity for a Senior QA Specialist to join the QA team in a South Dublin-based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 6 + years of experience providing technical QA support to pharmaceutical or biotech manufacturing operations and are ready for your next challenge, this could be the perfect project for you! ABOUT THE ROLE: Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation. Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards. Lead Quality review and approval of validation documentation associated with new facilities and new product introduction. Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable. Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements. Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations. Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas. Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction. Provide input and Quality Oversight for change control development and implementation. ABOUT YOU - ARE YOUR SKILLS A MATCH? University degree in a Science-related discipline. Minimum of 7 years' relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing). In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections. Experience working in aseptic operations, relating to vial and syringe filling. Understanding of principles of Validation and New Product Introduction. Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions). Apply directly via this advert or contact Siobhan Cummins on if you have any more questions about this opportunity! Please note that we are unable to provide work permit or visa sponsorship. Skills: QA Quality Quality Assurance Manufacturing Pharmaceuticals
LSC have a great contract opportunity for a Manufacturing Technology 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 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 Downstream (Purification Focus): to include buffer preparation, purification and viral reduction steps, including chromatography, ultrafiltration, viral reduction filtration and viral inactivation technologies and DS formulation and bulk fill. To identify and implement process improvements, e.g. yield, cycle time reduction through evaluation of process performance using data analytics tools. Provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies (e.g. health authority query support - timely responses / data gathering etc.). To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution. Identify or support process improvements (through change control or CAPA) and participate in implementation of Lean initiatives on site. Authoring of technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process. ABOUT YOU - ARE YOUR SKILLS A MATCH Minimum BSc or equivalent with at least 5 years' experience in drug substance manufacturing technical support in the biopharmaceutical industry. You have demonstrated awareness of cGMP compliance and regulatory agency requirements as well as strong oral communication and technical writing skills. Good interpersonal skills coupled with demonstrated ability to effectively work in a cross-functional global environment matrix organization, and in local group settings. Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. Can effectively partner with and influence stakeholders without direct solid line authority. Drives technical decisions balancing product quality and operational requirements. 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 Kathy Gillen on if you have any more questions about this role! Skills: Manufacturing Technology Specialist Processes Biopharmaceutical Pharmaceutical
LSC have a great contract opportunity for and QA Manager to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Cell based potency bioassays, lab operations and compliance. If you have 4+ 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 ROLE: Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA). Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners. Owner and approver of GMP/GDP QMS documents. Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation. Preparation and periodic review of Bona Fides. QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence. QA approval of change control proposals (third party contractors and internal) and action plans. ARE YOUR SKILLS A MATCH: Doctorate degree OR Master's degree & 2 years of directly related experience OR Bachelor's degree & 4 years of directly related experience OR Associate's degree & 10 years of directly related experience. 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry. Apply today directly through this advert or contact Kathy Gillen on for further information. All applicants must hold a valid work permit and visa for at a least 12 months. LSC cannot provide work permit sponsorship. Skills: Quality Quality Assurance Management Pharmaceutical QA Manager
LSC have a great contract opportunity for a Project Manager 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 7 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: Maintain a safe working environment by continuously promoting safety awareness, recognizing and rectifying unsafe conditions and performing thorough investigations when accidents occur. Take accountability for Project Design, Construction and C & Q activities on site through to end delivery. Liaise with the various internal and external stakeholders on the projects to ensure clear communication between all parties. Develop project concepts inclusive of design, constructability, risk identification and mitigation, costs, budgets and business drivers. Participate in and drive HAZOP and design reviews. Generate and manage QMS Change Controls for all Project activities. ABOUT YOU - ARE YOUR SKILLS A MATCH? 10 years minimum demonstrated Project Management, cross-functional Team Lead and Delivery experience in a commercial GMP Secondary Packaging/Labelling/Serialisation Environment. Bachelor's degree or similar in Engineering or Science (Mechanical, Chemical, E&I, P&I or related field). Demonstrated SME/Technical Experience with ownership of all packaging related deliverables within similar organisation. 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!
LSC have a great contract opportunity for an NPI Shift Engineer to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Cell based potency bioassays, lab operations and compliance. 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 project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Supports new product introductions to ADL PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME on the floor for these product and project executions. Support activities to deliver success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval. Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases. Development of validation plans, process performance qualifications for vial and 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) with a full understanding of CMC business process related to technology transfer. Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. ABOUT YOU - ARE YOUR SKILLS A MATCH? 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. Masters in Science or Engineering (preferred). 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 (preferred). 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 Kathy Gillen at if you have any more questions about this opportunity! Skills: Engineer Manufacturing Pharmaceuticals Shift Process Development
LSC have a great contract opportunity for a Senior NPI Shift Engineer to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Cell based potency bioassays, lab operations and compliance. 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 project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Supports new product introductions to ADL PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME on the floor for these product and project executions. Support activities to deliver success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval. Provide solutions when trouble shooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post-NPI phases. Development of validation plans, process performance qualifications for vial and 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) with a full understanding of CMC business process related to technology transfer. Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones. Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective. ABOUT YOU - ARE YOUR SKILLS A MATCH? 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. Masters in Science or Engineering (preferred). 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 (preferred). 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 Kathy Gillen at if you have any more questions about this opportunity! Skills: Shift Engineer NPI Lifecycle Management Process Development Manufacturing Pharmaceuticals.
