LSC have a great contract opportunity for a Senior Specialist, QC Quality Systems 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: * Lead and manage QC Investigations assigned * Facilitate root cause analysis and problem solving sessions * Complete the generation of associated investigation reports * Determine and create CAPA's, Effectiveness Reviews, and Supplemental Tasks as required * Present investigations at IRB to senior management * Leading and coordinating the initiation, implementation, and closure of QC Change Controls ABOUT YOU - ARE YOUR SKILLS A MATCH? * Education minimum of a B.Sc. Biochemistry or related discipline * At least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratory * A minimum of 1 years' experience with demonstrated effectiveness using quality systems (investigations/change controls - Trackwise/Infinity) in a FDA and EMA regulated environment * Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology, Raw Materials and Stability testing) is desirable 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 any more questions about this role!
An innovative biopharmaceutical company in Limerick is seeking a Commissioning & Qualification Lead / Project Manager Consultant. Candidates should have at least 10 years of experience in the pharmaceutical or biotechnology industry. The role involves overseeing commissioning and qualification activities, ensuring that systems are ready for operations, and providing expert troubleshooting support. Applicants must be eligible to work in Ireland with the appropriate visa. #J-18808-Ljbffr
LSC have a great contract opportunity for a Commissioning & Qualification Lead / Project Manager Consultant to join an innovative and rapidly growing Biopharmaceutical company in Limerick. 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: Prior to commissioning drive and track deliverables to completion - engineering and qualification documentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc. Support the handover of systems to operations by ensuring all issues are resolved and systems meet operational requirements. Oversee onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning. Lead and oversee the execution of commissioning and qualification (CA, CTP, IQ, OQ, PQ) activities as per pre-approved protocols. Act as the primary point of escalation for troubleshooting and resolving issues during C&Q execution. Provide hands‑on support to the C&Q team in identifying and addressing system issues ABOUT YOU - ARE YOUR SKILLS A MATCH? Minimum of 10 years of experience in commissioning and qualification in a regulated biopharma or pharmaceutical environment. Demonstrated expertise in troubleshooting and problem-solving during C&Q execution. Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities). 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 at LSC on if you have any more questions about this role! #J-18808-Ljbffr
LSC have a great contract opportunity for a QA Analyst 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 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: Execute and assist in batch release testing, technical transfer and co-validation activities. Accurately documenting laboratory work. Data review based on demonstrated proficiency on assays. Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports. Assisting in updating and issuing documentation, including SOPs, as required. Assisting with qualification of laboratory instruments. ABOUT YOU - ARE YOUR SKILLS A MATCH? One to two years' experience in the following analytical techniques would be an advantage: Aseptic Techniques, Cell Culture, Cell-based Bioassays and ELISA. The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline. 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: Aseptic Techniques Cell Culture Cell-based Bioassays
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. Apply via this advert or contact Kathy Gillen on if you have any more questions about this role. As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply. LSC do not provide work permits or visa sponsorship.
LSC have a great contract opportunity for a Commissioning & Qualification Lead / Project Manager Consultant to join an innovative and rapidly growing Biopharmaceutical company in Limerick. 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: Prior to commissioning drive and track deliverables to completion - engineering and qualification documentation, FAT/SFAT executions, VTOPS reviews, Asset Builds etc. Support the handover of systems to operations by ensuring all issues are resolved and systems meet operational requirements. Oversee onsite setup and shakedown of new systems and equipment to ensure functionality and readiness for commissioning. Lead and oversee the execution of commissioning and qualification (CA, CTP, IQ, OQ, PQ) activities as per pre-approved protocols. Act as the primary point of escalation for troubleshooting and resolving issues during C&Q execution. Provide hands-on support to the C&Q team in identifying and addressing system issues ABOUT YOU - ARE YOUR SKILLS A MATCH? Minimum of 10 years of experience in commissioning and qualification in a regulated biopharma or pharmaceutical environment. Demonstrated expertise in troubleshooting and problem-solving during C&Q execution. Strong knowledge of biopharma equipment and systems (e.g., bioreactors, chromatography columns, filtration units, utilities). 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 at LSC on if you have any more questions about this role!
LSC have a great contract opportunity for a Sr Associate QC to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. 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: - Testing of in process, stability and finished product samples. eg HPLC, CE, SDS-PAGE, IEF analytical testing, characterization and sample and data management. - Review and authorisation of Lab Data - Support Analytical Technical Transfer activity testing reports and documentation. - Document review/updates when required. - Equipment Calibration, Maintenance and Trouble Shooting. - Method Validation/Verification. ABOUT YOU - ARE YOUR SKILLS A MATCH? - Hold a third level qualification (Degree/Diploma) in Biochemistry, Chemistry, Biology Biotechnology or similar Scientific Subject. - Have at least 5 years relevant experience in a pharmaceutical/healthcare environment. - Be very proficient in the use of Microsoft Word, Excel etc. Apply via this advert or contact Kathy Gillen on if you have anymore questions about this role! All applicants must hold an Irish work permit/visa valid 12 months. LSC do not offer visa sponsorship.
LSC have a great contract opportunity for a L&D Specialist to join a Limerick based company to play an integral part in developing the Site Training Content/Systems / Programmes for this manufacturing site. ABOUT THE PROJECT - KEY RESPONSIBILITIES: Support activities in the design, development and management of training materials, curricula, and learning plans for a designated function of the business. Assist in the creation and management of training documents in accordance with site Training SOPs. Produce reports from Learning Management System. Training compliance. Support training qualification compliance management. ABOUT YOU - ARE YOUR SKILLS A MATCH? Relevant Third Level Qualification 5+ years experience in a similar training support or learning and development role within GMP manufacturing Familiarity with cGMPs requirements preferred To apply for this contracting position you must possess a Stamp 1G or a Stamp 4 work permit. LSC cannot provide work permit sponsorship. Apply via this advert or contact Cian Marnane on if you have any more questions about this opportunity! Skills: Learning & Development Training Systemsd GMP Manufacturing
LSC have a great contract opportunity for a C&Q 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: Co-ordination/Execution of Protocols to meet project schedules etc. Ability to manage workload of multiple projects of varying complexity. Generation of System Traceability Matrices, C&Q Risk Assessments, C&Q plans, test cases and reports Experience in writing protocols, traceability matrix's, DQ's. The engineer needs to have brought a project through commissioning/DQ/IOQ/RTM life cycle. Document generation and execution for assigned systems (FAT, SAT, RV, IV, OV). ABOUT YOU - ARE YOUR SKILLS A MATCH? A BEng or BSc degree is preferred 5 years + experience in C&Q on projects in the Pharmaceutical/Biotechnology industry Experience in Packaging is desirable. 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: Commissioning Qualification Validation
LSC have an exciting contract opportunity for QC Analyst to join a leading biotechnology company based in Dublin and make a real impact in the field of quality control. The Sr Associate QC position is perfect for those who have 3+ years biopharmaceutical QC experience with product testing in a GMP laboratory setting.. ABOUT THE ROLE: Perform a wide variety of assays, including routine and non-routine methods Evaluate and approve analytical data, ensuring compliance with cGMP standards Troubleshoot issues and communicate effectively with stakeholders Participate in audits, initiatives, and cross-functional projects ARE YOUR SKILLS A MATCH: Bachelor's degree in a Science-related field 3+ years of biopharmaceutical QC experience or related GMP laboratory experience Experience with analytical techniques such as pH, clarity, and osmolality testing Detail-oriented with excellent problem-solving abilities Self-motivated and capable of working independently Proven track record of meeting deadlines and working effectively in a team 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.
