LSC have a great contract opportunity for a Quality Assurance Specialist to join a South Dublin based Biopharmaceutical company. If you have 8 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 1. Operational Readiness, Validation & Documentation * Provide QA leadership duringdesign of new rooms, development of materials/people/waste flows and contamination controls (gowning, cleaning, desinfection)ensuring operational robustness. QA review/approve associated risk assestments and SOP. * Review and approve validation documentation including integrated line PQs, media fills, and environmental monitoring qualifications. * Support QA review of MBR and recipe creation for filling, lyophilization, and associated aseptic operations. 2. Technology Transfer & New Product Introduction (NPI) * Serve as the QA Lead for technology transfer and NPI activities, providing quality oversight throughout process validation and product lifecycle introduction. * Review and approve technology transfer documentation including process descriptions, PPQ protocols, validation reports, and risk assessments. 3. Quality Systems, Risk Management & Compliance * Lead and support deviation, CAPA, and change control management related to operational readiness, validation, and tech transfer activities. * Conduct quality risk assessments for new processes, interventions, and aseptic operations. * Ensure data integrity and right-first-time execution across all readiness and validation deliverables. Education: * Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related discipline. Experience: * Minimum 8 years' experience in pharmaceutical or biotechnology manufacturing * Proven expertise in facility startup and Quality Oversight of Operational Readiness and and technology transfer knowledge of applicable regulatory requirements and experience with regulatory inspections including EU/FDA GMP, Annex 1, and process validation lifecycle requirements. * Experience working in aseptic operations, relating to vial and syringe filling. * Experience managing change control, deviations, and CAPAs through electronic QMS systems (e.g., TrackWise, Veeva Vault, PAS-X, SAP). About you - Are your skills a match? 8 years working in Quality Assurance Strong technical understanding of Aseptic manufacturing and Validation Excellent collaboration, communication, and decision-making skills. Analytical and pragmatic approach to quality risk management. Ability to balance regulatory compliance with operational efficiency. 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 Siobhan Cummins on if you have anymore questions about this role!
LSC have a great contract opportunity for a QC Micro Senior Analyst 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 opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Environmental Monitoring of Grade 8/9 Cleanrooms Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators Bioburden testing of water & disinfectants Testing of in?process samples (Protein Concentration, Density & pH) Writing technical reports ABOUT YOU - ARE YOUR SKILLS A MATCH? Bachelor's degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products 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 Caoimhe O Sullivan on if you have anymore questions about this role! Skills: Environmental Monistoring Micro LIMS
LSC is seeking an Account Manager who will manage leads, pipeline new opportunities and promote campaigns to existing and new LSC clients. The Account Manager will focus on building strong working relationships with existing key client contacts to ensure up to date information on client requirements. The Account Manager will also liaise with the Contracts Management team and help with the management of LSC personnel on site to ensure a smooth onboarding and continuing high level of service to LSC clients. GENERAL SCOPE OF RESPONSIBILITIES: Drive growth by promoting LSC services to target clients Develop relationships through phone, email, social media and professional networking Manage LSC contacts and relationship with existing clients Identify and develop new relationships with other prospective hiring managers within the Account Analyse and present monthly analytics to management Work towards assigned business and pipeline goals while prioritizing an outstanding client experience. Contribute to LSC sales and marketing strategy in generating and developing business growth opportunities. Work with marketing as a critical member of a sales team and work closely with LSC clients and partners - to maximize results and open up new opportunities. Lead generation and qualification, promote client campaigns from conception, planning, execution, and launch to post-launch analysis. Explore and understand complex customer requirements to create a strategic plan of action. Focus on UX and driving the development of new products and service offerings to ensure best in class service to our clients. Prepare and conduct presentations, while maintaining effective communication. Timely and accurate updating of Account Plans for key clients assigned. Achieving targets set within the Account Plans. Regular review of account plans with LSC Management to consistently manage & improve performance of the account to ensure sustained growth on key accounts. Management of existing & new client contacts. Quarterly onsite presence on all key accounts assigned. Actively manage all issue escalations on key accounts. Actively manages all open vacancies to ensure all required information is available to the recruitment team in a timely manner. Working closely with client contacts on initial offers and closing out offers. Working closely with client contacts on contract extensions, rate reviews and closing out. Management of new contract or contracts changes with existing consultants. Review and negotiate new client contracts and client contract extensions, ensure all T&C's and compliance requirements flow down and are accurately captured for the LSC contracts and compliance team. KEY COMPETENCIES REQUIRED: Excellent interpersonal skills as well as excellent communication skills, both written & verbal. Ability to operate as part of a team is critical & also ability to self-manage and work independently. Customer focused & Innovative. Attention to detail. Results and performance driven. Adaptable and flexible. Ability to manage ambiguity. QUALIFICATIONS AND EXPERIENCE: 3rd level qualification in a scientific/technical/business discipline a distinct advantage. Life Science experience is a distinct advantage Account Management &/or Customer Service &/or sales experience. To From Record Yes No Always use these settings To From Record Yes No Always use these settings To From Record Yes No Always use these settings Skills: sales account manager account management business development
LSC has an exciting opportunity for a Site Transformation Project Manager 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. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture. 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: The Site Transformation Project Manager is responsible for central coordination and oversite of the site modernisation and digitalisation strategic initiative Reporting progress and escalating needs to senior leadership Resource loading and prioritisation of initiatives Detailed planning and PM oversight of several transformation projects. ABOUT YOU - ARE YOUR SKILLS A MATCH? Applied knowledge/experience of project management for a cross-functional team is preferable. Applied knowledge of Smartsheet is preferable. Minimum of 5 years of work experience in manufacturing/NPI and/or project management. 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: Cork
LSC have a great contract opportunity for a Project Engineer to join a Kerry based Biopharmaceutical company. If you have 3+ years of experience working in the pharmaceutical or biotechnology industry , then please reach out. This might be the ideal role for you! RESPONSIBILITIES: Project management and execution of assigned projects including project prioritization, resources management, status management and external communication. Working with various stakeholders, to scope projects and ensure requirements are satisfied. Project input will span from concept, through design, construction, commissioning and operation Coordinating the introduction of new processes, equipment and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up EDUCATION/EXPERIENCE: Bachelor's Degree in Engineering (Mechanical, Electrical or Chemical) or Relevant Experience Typically, 3+ years project engineering experience, preferably in the biotechnology industry Proven full project management lifecylce experience. Apply via this advert or contact Cian Marnane at LSC on if you have any more questions about this role! Skills: Project Management Full Project Lifecylce Process Equipment
LSC have a great contract opportunity for a QC Micro Senior Analyst 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 opportunity for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Endotoxin testing of water, in-process and drug product release samples Bioburden testing of water & in-process drug product samples Sterility testing Water sampling Lab Support duties such as Biological Indicator testing, Growth Promotion, Media Preparation, Identifications and Autoclave. ABOUT YOU - ARE YOUR SKILLS A MATCH? Bachelors degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products 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 Caoimhe O Sullivan on if you have anymore questions about this role! Skills: Endotoxin Bioburden Micro
LSC have a great contract opportunity for a Manufacturing Projects Scientist 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 supporting manufacturing 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: Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes. Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing Represent the Manufacturing at meeting to ensure the end user requirements are represented Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches. ABOUT YOU - ARE YOUR SKILLS A MATCH? Ability to demonstrate proficiency communicating and collaborating at a variety of levels, coupled with excellent organization and planning skills. Proven success working in a team environment, as well as strong leadership & influencing skills, with flexibility to react to changing business needs. Problem solving and project management ability, as well as lean manufacturing experience is essential. Currently completing a Bachelors/Masters in Science, Engineering, or a related subject. In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation. Apply via this advert or contact Kathy Gillen on if you have any more questions about this role! 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!
LSC have a great opportunity for a Manufacturing 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 manufacturing 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: The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and analytical knowledge to complete the following: Key Responsibilities: Manage deviation investigations, including establishing investigation teams, leading root cause analysis, development of CAPAs, completing product impact assessments and writing comprehensive compliant documentation of all findings. Clear and concise technical writing of complex investigations Drive improvements to the investigation process Present investigations to regulatory inspectors and internal auditors Clearly communicate investigation progress to impacted areas and leadership Coordinate and lead cross-functional teams through complex investigations, and complete tasks on-schedule. Project management of the investigations end to end Requirements: Bachelor's Degree in Science or Engineering and 5+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) OR * Associate's Degree in Science or Engineering and 8+ years of directly related experience in a biotech/pharma manufacturing or manufacturing support role (ie process development, engineering, quality) * 10+ years directly related experience in a biotech/pharma manufacturing or manufacturing environment Detailed technical understanding of fill/finish operations Experience with compliance, problem-solving, root cause analysis, critical thinking, project management, and quality systems. Experience leading complex investigations Experience participating in and leading cross-functional teams Experience in managing multiple, competing priorities in a fast-paced environment Experience presenting to inspectors during regulatory inspections and internal audits. Apply directly via this advert or contact Kathy Gillen on if you have any more questions about this opportunity! Please note that we are unable to provide work permit or visa sponsorship.
LSC have a great contract opportunity for a Process 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: Provide technical engineering support and expertise to Packaging & Labelling Operations including equipment performance monitoring, equipment recipe standardisation troubleshooting and process optimisation Represent Engineering on the Packaging & Labelling Operations Process Team and support to deliver uninterrupted supply of commercial product. Fulfil system ownership responsibilities for all packaging equipment and associated automation recipes required for packaging operations Process Engineering system owner representative on key capital projects for area expansion currently being implemented in Packaging across different suites. ABOUT YOU - ARE YOUR SKILLS A MATCH? BA Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework 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: Engineering- Process Mechanical Chemical
LSC have a great contract opportunity for a Sr Document Controller to join the client project team on a major 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. The role is fully embedded on site and responsible for the client-side control and governance of all project documentation across design, construction, CQV and handover phases. If you are an experienced Document Controller with 5 + years experience in a similar role this could be the next contract for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Client-side control of all project documentation across the full lifecycle Manage document receipt, review, approval, issue, revision control and archiving Interface with EPCM partners, vendors, contractors and internal stakeholders Ensure documentation complies with GMP, data integrity and ALCOA+ principles Maintain accurate document registers, trackers and status reports Support CQV documentation, executed protocols and final turnover to operations Support audits, inspections and project close-out activities ABOUT THE PROJECT - KEY RESPONSIBILITIES: Proven experience as a Document Controller on pharmaceutical or life sciences capital projects Essential: hands-on experience using EIDA for document management Experience working client-side or within an owner's project team Strong understanding of GMP documentation requirements Experience supporting construction, commissioning and qualification documentation Ability to work full-time on a live pharmaceutical site in Ireland Desirable Experience on large-scale Irish pharma projects (drug product, biologics, sterile facilities) Familiarity with ValGenesis, Kneat, ACC or similar platforms Apply via this advert or contact Kathy Gillen on if you have any more questions about this role!
