Job DescriptionAbout 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.Overview:As part of the IPT team, perform various production and operations related tasks as part of an empowered team to aid in the manufacture and reliable supply of product. Ensure that objectives are effectively achieved, consistent with requirements to ensure compliance, safety and reliable supply to our customersRequirementsKey Accountabilities:With a RFT mindset operate and/or monitor production activities and support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs. Equipment will include, yet is not limited to, parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger and filling machinesClean room cleaning, housekeeping and materials management in all production areas while focusing on continuous process improvement using Lean Principles.Fully Certified and Proficient on all Equipment, Processes and Tasks in the room.Knowing factory priorities/schedule through RTMS. Acting proactively without direction.Manage equipment flow, including tracking soiled and clean hold times, proper labeling and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment.Maintain process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks.Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with same.Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.Highlights roadblocks or issues from a people, safety, quality or delivery perspective in a timely manner.Able to perform routine day to day problem solving for assigned area independently or when working as part of a teamEngage in Tier 1 process at both start and end of shift. Asking relevant questions and providing detailed informationRequired to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.Take ownership of your own safety & adhere to all safety procedures and programs.Obtain and Maintain all required safety certifications independently.Work collaboratively to drive a safe and compliant culture.May be required to perform other duties as assigned.Job Requirements:This role is a site-based role.This a 24/7 shift role.Clear understanding and demonstrated cleanroom, sterile behaviors & ALCOA PrinciplesHighlights roadblocks or issues from a people, safety, quality or delivery perspective in a timely manner Highlights roadblocks or issues from a people, safety, quality or delivery perspective in a timely mannerEager to learn and progress and take feedbackFlexible and engaged in Shift Versatility.Involved in training fellow work matesEngaged in EnablonManual Handling, Material transfer & Pallet truck CertificationsPSA/Airlock Management. Knowing what good looks like.Engaged in TAT and a clear understanding of zones and expectationsUnderstanding of logging Down Time and using SEEQValidations, Tech Eng & Maintenance support where required.Basic Batch review/release & PO Closures.1 Improvement Project or OPPs completed Per YearEducational and Experience RequirementsTypical Minimum Education: Leaving Certificate or equivalent required;Apprenticeship, Certificate or Diploma preferred; ideally in a related discipline