About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.'Take your Career to a new Level'PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the "heartbeat" of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client's expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.PSC Biotech is hiring fo one of our clients in Dundalk a Support Specialist.REQUIREMENTS:Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.Coordinate technical deliverables within Drug Substance to support the successful product launch.Provide technical support to the operations team's during commercial manufacturing.Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.Support Batch Disposition activities by providing SME technical support for comment resolution.Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.RequirementsREQUIREMENTS:Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six SigmaExperience in a risk-based approach to manufacturing through use of tools such as FMEAAbility to adapt to changing priorities as project demands changeEDUCATION:Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.OTHER SKILLS, ABILITIES & EXPERIENCE:Previous experience in an operations role within vaccine manufacturing preferred.Knowledge of USP1790 and industry/ regulatory requirements such as Annex 1 desirableExperience in DS process such cell culture, downstream processesExperience in start-up facility advantageousDemonstrated excellence in planning and organizational skills.Demonstrated skills in communication (oral and written) & in particular technical writing.