LSC have a great opportunity for a QA Specialist - Technical Support to join the QA team with our Biopharmaceutical client based in South Dublin that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging. If you have 5 + 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 and oversight for key functional areas (i.e. Inspection, Validation, Quality Control, Engineering, ), ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations. Quality review and approval of Validation documentation and SOPs to support site validation activities: Review of DS & QRAES documents Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents Review of executed validation documents and reports ABOUT YOU - ARE YOUR SKILLS A MATCH? University degree. Science or Engineering related discipline preferred. Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Packaging, Inspection, Validation, Quality Control, Engineering, Information Systems) Understanding of principles of Validation and New Product Introduction Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Ability to operate across functional boundaries, both internal and external. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. Strong organisational, communication, coordination, and meeting facilitation skills. Apply directly via this advert or contact Kathy Gillen on if you have any more questions about this opportunity! Please note that LSC do not provide work permit or visa sponsorship.
LSC have an exciting opportunity for Quality Assurance (QA) Associate to work on our client site, a state-of-the-art biotech company based in Dublin. As an Associate in Quality Assurance you will be an active member of the QA team and will be assigned to the IQA Quality functional area, which is responsible for the inspection and release of primary packaging components. This is a days and late shift role. ABOUT THE ROLE: Conduct testing of primary and secondary components for aseptic product manufacturing Sample Excipients and Drug Substance under Grade C conditions Review and approve documentation for QA Specialist or Qualified Person disposition activities Participate in customer complaint investigations with component suppliers Provide training and advice on component and packaging testing Actively contribute to audits and their preparation Support continuous improvement and Operational Excellence initiatives ARE YOUR SKILLS A MATCH? University degree, preferably in Engineering or Science-related discipline 4+ years of relevant experience in the pharmaceutical or biotechnology industry Must pass Eye-Tests required for Visual Inspection Excellent written and verbal communication skills Strong problem-solving abilities and experience in managing Root Cause Analysis / Non-Conformance / Deviation investigations Experience in aseptic operations, protein formulation, vial and syringe filling is preferred As a QA Associate Shift, you'll be part of a world-class team in a state-of-the-art facility. The company offers competitive compensation, including a 20% shift rate, and the potential for contract renewal beyond the initial 12-month period. You'll have the opportunity to work on groundbreaking projects, including a $100M vial filling line installation, and contribute to the company's mission of serving patients around the world. Ready to take your career to new heights as a QA Associate? Apply now by submitting your resume and cover letter to this advert or call Kathy Gillen on for more details. All applicants must have a valid work visa for 12 months. LSC does not provide work permits or visas.
LSC have an exciting contract opportunity for a Sr Quality Assurance Specialist to join a leading biotech company based in Dublin. This is your chance to be part of groundbreaking projects and ensure the highest quality standards in pharmaceutical manufacturing. As a Sr Quality Assurance Specialist - Technical, you'll be at the forefront of biotechnology innovation, working on high-impact projects that make a real difference in patients' lives. The company offers a collaborative work environment, state-of-the-art facilities, and the opportunity to work with cutting-edge technologies. The Sr Quality Assurance Specialist role offers a unique blend of technical expertise and strategic thinking, perfect for those who thrive in a fast-paced, cutting-edge environment. Primary responsibilities Lead QA oversight for operational readiness, validation, and technology transfer activities Review and approve critical validation documentation for integrated line qualifications and media fills Provide QA leadership in designing new rooms and developing contamination control strategies Serve as the QA Lead for technology transfer and new product introduction activities Manage quality risk assessments and ensure compliance with global validation standards Qualifications and Skills Bachelor's or Master's degree in Science, Engineering, Biotechnology, or related field with minimum 8 years' experience in pharmaceutical or biotechnology manufacturing Proven expertise in facility startup and Quality Oversight of Operational Readiness In-depth knowledge of EU/FDA GMP, Annex 1, and process validation lifecycle requirements Experience in aseptic operations, particularly vial and syringe filling Strong technical understanding of aseptic manufacturing and validation Excellent collaboration, communication, and decision-making skills If you're passionate about quality assurance in biotechnology and ready to take on the challenge of a Sr Quality Assurance Specialist Technical role, we want to hear from you! Apply now by sending your CV and a brief cover letter outlining your relevant experience or contact Kathy Gillen on for more details. Please note all applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
LSC have an exciting opportunity for a QC Sample Management Specialist with our client a state-of-the-art multi-product cell culture drug substance Facility in Dublin. As a QC Sample Management Specialist at this world-class facility, you'll be at the forefront of biologics manufacturing part of a team dedicated to improving patients' lives through innovative therapies. ABOUT THE ROLE Manage and process Drug Substance, Drug Product, and Raw Material samples with precision and efficiency Collaborate with manufacturing, engineering stores, and warehouse logistics to ensure timely sample delivery Expertly handle TempTales and shipping documents for external samples Maintain meticulous sample logging and labeling in LIMS/CIMS systems Perform crucial monthly reconciliations and report any deviations Support buffer preparation for QC Separations lab Generate and update SOPs to maintain the highest GMP compliance standards ARE YOUR SKILLS A MATCH? Degree in Chemistry, Biology, or a related scientific discipline Minimum 1 year of experience in a pharmaceutical/healthcare laboratory or related technical function Strong understanding of cGMP regulations and laboratory operations Excellent written and verbal communication skills Ability to thrive in a collaborative, team-based environment Keen attention to detail and strong organizational skills Please apply directly via this advert or contact Kathy Gillen on to discuss this opportunity in more detail. All applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
LSC have a great contract opportunity for a Packaging 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: 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, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling and Packaging 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!
LSC have an exciting opportunity for Contract Development and Manufacturing Manager Our client, a cutting-edge biotech manufacturer based in Dubin, is seeking a dynamic professional to lead their external process development initiatives. As a Contract Development and Manufacturing Manager, you'll be at the forefront of innovative drug development, working with state-of-the-art technologies and world-class teams. Primary responsibilities Spearhead laboratory supplier relationship management, developing metrics and monitoring performance to drive continuous improvement Manage a portfolio of cross-disciplinary external projects in Drug Product, Drug Substance, and Attribute Sciences Lead delivery of analytical work packages with external contract laboratories Ensure quality, cost, and delivery targets are consistently met for Contract Testing Laboratory sites Identify project optimization opportunities and prioritize a rolling portfolio of projects Conduct supplier evaluation and selection processes Qualifications and Skills Master's Degree with 3 years of Scientific experience OR Bachelor's Degree with 5 years of Scientific experience Advanced degree in engineering or sciences preferred 5 + years experience in large molecule analytical development including method development, method qualifications/ transfers/validations, release, stability and characterization testing. Strong understanding of cGMP, Regulatory/CMC, legal, Quality requirements, and import/export policies Proven business acumen and strategic thinking abilities Excellent project management and communication skills Why Join Us? As a Contract Development and Manufacturing Manager, you'll be part of a company that's been named one of the World's Best Workplaces by Fortune and Great Place to Work. This hybrid role offers flexibility, requiring onsite presence just 2 days per month. Join a team that's investing in the future, with recent announcements of an €88 million investment in a new vial filling line! Please apply directly via this advert or contact Kathy Gillen on to discuss this opportunity in more detail. All applicants must have a valid work permit for at least 12 months. LSC do not offer work permit or visa sponsorship.
LSC has an exciting opportunity for a QA Rep to join a pharmaceutical company in Cork. ABOUT THE PROJECT - KEY RESPONSIBILITIES: QA rep supporting small molecule and peptide manufacturing processes Review and approval of change controls and failure investigations Maintenance of all aspects of GMP compliance Collaborate closely with quality and process teams to ensure adherence to the highest quality standards ABOUT YOU - ARE YOUR SKILLS A MATCH? Degree in Chemical Engineering, Science, or a related field Minimum of 5 years of experience in a QA Rep role within the pharmaceutical industry Proficiency in SAP and Trackwise systems Strong understanding of deviation and change control processes Experience in continuous manufacturing is highly 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! Call Cian Marnane LSC on to discuss in detail or apply directly via this advert. Skills: API Manufacturing Deviation Investigation Change Controls
An exciting opportunity for QC Infrastructure Analyst! LSC are seeking a talented QC Infrastructure Analyst to join a leading biopharmaceutical company dedicated to developing groundbreaking therapies for rare genetic diseases. This is your chance to be part of a team ensuring the safety and efficacy of life-changing medications! Primary responsibilities Execute and support vendor IQ/OQ/PQ protocols for cutting-edge laboratory instrumentation Develop and write protocols for instrument qualification/validation studies Troubleshoot instrument performance issues and maintain GMP compliant records Support change control activities and perform impact assessments for QC equipment Write and review SOPs relevant to laboratory instrument and software operation Qualifications and Skills Minimum of three years pharmaceutical experience in science, engineering, or a related discipline Strong working knowledge of QC Analytical systems Excellent project management skills and ability to manage multiple stakeholders Self-directed with a keen eye for detail and commitment to quality Strong communication skills and ability to work in a collaborative environment Apply directly through this advert or call Kathy Gillen on for more details. All applicants must have a work permit for Ireland that is valid for at 12 months. LSC do not provide sponsorship for work permits or visas.
LSC have a great contract opportunity for a Computer Systems QA Specialist to join a Cork based Biotech Drug Substance Manufacturing Facility. If you have at least 5 years of relevant experience in a cGMP environment and ready for your next challenge, this could be the perfect project for you! ABOUT THE PROJECT - KEY RESPONSIBILITIES: Provide Quality leadership, direction, and governance for MES and MES related systems. Manage Quality-related matters specific to area (Quality system or Quality Program) of responsibility. Approve appropriate quality-related documents. An approval signature confirms that site and GMP requirements have been met. Carry out day-to-day activities in compliance with site safety policies and procedures.? Promote and encourage safe practices and promptly report any safety concerns. Promote and encourage Quality culture and promptly report any compliance concerns. ABOUT YOU - ARE YOUR SKILLS A MATCH? May hold BSc, MSc or PhD in Chemistry, Engineering, or related discipline Expertise in lab equipment and lab systems Strong background in validation and compliance. Will need to be skilled in project delivery /timeline delivery For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. Apply via this advert or contact Cian Marnane at if you have any more questions about this opportunity! Skills: Lab Systems QA Compliance Project Delivery
LSC have an exciting opportunity for CQV Engineer to support projects in a cutting-edge pharmaceutical company based in Co. Wicklow. As a CQV Engineer in the project group, you'll play a crucial role in shaping the future of pharmaceutical manufacturing. ABOUT THE ROLE? Lead commissioning and qualification activities for state-of-the-art process and packaging equipment, facilities, utilities, and computerized systems Develop, review, and approve cGMP documentation for equipment, facility, utility, and computerized systems validation Drive project success from design through commissioning and qualification phases Manage vendor relationships and ensure compliance with quality standards Spearhead change control initiatives and foster a culture of continuous improvement ARE YOUR SKILLS A MATCH? Bachelor's degree in Engineering, Science, or a related technical field (engineering degree preferred) Minimum 5 years of experience in pharmaceutical manufacturing, validation, operations, or engineering Proven validation expertise in Process and Packaging Equipment (OSD), Facilities and Utilities, and Computerized Systems. Strong technical writing skills and experience with GMP documentation Proficiency in risk assessment and risk-based approach to validation activities Experience with Electronic Documentation Management Systems (KNEAT, VEEVA, TRACKWISE) Excellent problem-solving abilities and innovative thinking Apply directly through this advert or contact Kathy Gillen on to get more details on this great opportunity. Applicants must have a 12 month valid work visa for Ireland. LSC do not offer visa or work permit sponsorship.
