About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud -based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. 'Take your Career to a new Level'PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like -minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse -cultural work setting. Employee Value PropositionEmployees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin -house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Overview:A fantastic and exciting opportunity has arisen for aManufacturing Biotech Associate that will work in a manufacturing self -directedshift team to deliver batch operations successfully, identify and resolveissues in order to allow the site to deliver for our patients in a culture thatsupports Quality, EHS, Learning and Continuous improvement.
RequirementsResponsibilities:Support operations team to consistently deliver onspecific Key Performance Indicators (KPIs), e.g. Environmental Health andSafety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE),compliance and team training.Complete COMMIT cards to highlight ways of working withinour SDWT's and Hubs and across our site that support our COMMIT culture.Provide immediate feedback to others at any time toreinforce good safety and improvement behaviours and acts.Execute commercial manufacturing processes according toestablished work instructions and Standard Operating Procedures (SOPs).Ensures that all assigned task related to manufacturingdocumentation support is in accordance with good manufacturing practices.Routinely talk about any safety issues you are concernedabout.Work as part of a dedicated process team whereflexibility and teamwork are a key requirement.Generate SOPs/ Work Instructions (WIs) to ensurecompliance with regulatory standards.Adhere to Right First -Time principles.Provide assistance and/or support maintenance,engineering, quality or other colleagues as requested.Escalate issues as appropriate to manager/designee.Maintain a high level of personal expertise and workingknowledge of all aspects of the manufacturing process and process equipmentthrough continuous training and development.Liaise with other groups and individuals to ensureplanning of tasks is effective and linked into the manufacturing process planand site schedule.Challenge and identify improvements to the safety andenvironmental programmes on site.Celebrate with use of proactive recognition tools thatinspire teams and individuals you collaborate with.Take part in shift handovers and tier 1 meetings, raisingconcerns or issues promptly and providing options for resolutions.Act as an ERT during emergency situation if trained .Maintain/ support a high standard of safety/ GoodManufacturing Practice (GMP) compliance at all times.Determine solutions by referencing relevant pastexperiences as part of problem solving activities.Get actively involved by participating in inspections,GEMBA's and Go -See's.Act as a team member on process deviation reviews andGemba walkdowns.Mentor new members of staff in specific plant activities.Be prepared to answer auditor questions during sitewalkdowns.Engage in implementing innovative solutions that drive ahigh performance organisational culture that accommodates rapid growth andhighly dynamic expectations ensuring attainment of site operational anddevelopment goals.Utilize Lean Six Sigma Tools to support the initiative ofcontinuous improvement (CI) projects to increase agility, flow, throughout andreduce cycle time and inventory.This is a 24/7 shift role