Downstream Manufacturing Support Engineer Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years City: Dublin State/Province: Dublin Country: Ireland Job Description About PSC Biotech 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. Role Functions: Work as a key team member within the Downstream (DS) Integrated Process Team (IPT) to ensure on-time delivery of the production schedule while maintaining alignment with site safety and quality standards. Provide oversight on material management, ensuring quality and delivery metrics related to material management are always maintained. Own Quality Investigation from identification through root cause analysis. Provide oversight on day-to-day production quality metrics ensuring on-time documentation closure, line clearance, and material management as per area SOPs. Drive continuous improvement projects related to schedule, equipment, and delivery capability within the DS IPT. Act as a link between the shift operations team and day team, ensuring standardization and integration between all IPT teams. Support audit readiness in the BDS and drive a permanent audit readiness culture within the team. Direct Root Cause Analysis (RCA) sessions for both safety and quality related events, driving actions to closure with appropriate corrective/preventive measures. Lead/support area change controls, CAPAs, QSAT Actions as relevant per workstream as well as completing documentation updates as required. Provide ongoing coaching and support to cross-functional team members, to share process and operational best practices. Act as day operations member on process-centered teams (PCT), working with technical operations and shift operations to identify, perform root cause analysis, and develop corrective/preventive actions for issues as they occur. Requirements A Level 7 Degree in Science, Engineering, or other relevant disciplines/relevant experience preferable. Experience across multiple site functions (including but not limited to Quality, Engineering, or Supply Chain) desirable but not required. Experience in change management in a GMP environment. Experience in technical writing for GMP documentation and quality investigations. Self-motivated with excellent organizational skills. Excellent verbal and written communication skills. Proficient in Microsoft Office Tools (Word/Excel/PowerPoint). Ability to work independently and as part of a team in a cross-functional collaborative environment. High level of attention to detail. Experience working with GMP Documentation Management Systems. Good interpersonal skills. Qualifications: At minimum Level 7 in a relevant Qualification. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? 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 points 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 to working in top pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through 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. Role Description: Responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing. Ensure that objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety, and reliable supply to our customers. Requirements Role Functions: Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs, and troubleshooting. Required to operate and clean the process equipment as necessary. Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting, and repairs to ensure continuous, reliable, and repeatable operation of all equipment; drive Total Productive Maintenance. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtime. Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs, etc. Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. Operate and monitor production support equipment, using MES/DCS and PLC-based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles. Operate, troubleshoot, and repair complex systems which may include CIP, Autoclaves, Glassware Washers, production vessels, HVAC, Isolators, compressed gases, plant steam/condensate, bulk chemical distribution, and wastewater treatment under minimal supervision in a highly regulated, cGMP environment. Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Support continuous improvement by leading and actively participating in repairs, upgrades, preventative maintenance, and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s, etc.; implement subsequent corrective action through the change management system. Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems, etc. as necessary. Assist in general facility upkeep and provide responsive customer support with emphasis on customer satisfaction. Participate effectively in writing/revising/rolling out accurate operational procedures, training materials, and maintenance procedures for various IPT systems; ensure all work is carried out in line with same. Leadership activities including selection, development, coaching, and day-to-day management. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes. Required to comply with client 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. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills: Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. Technical: Troubleshooting and maintaining process instrumentation and equipment. Understanding of mechanical/electrical/Instrumentation/pneumatic processes. Sterile filling processes. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards, and Practices. Proficiency in Microsoft Office and job-related computer applications required. Business: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers. Understand the specific responsibilities of all Carlow departments as they relate to one's own department, understanding the business processes one's department supports. Self-motivated. Flexible approach. Leadership: Focus on Customers and Patients. Act with Candor and Courage. Make Rapid, Disciplined Decisions. Drive Results. Build Talent. Demonstrate Ethics and Integrity. Qualifications & Education: Leaving Certificate or equivalent required. Time-serviced Electrical/Electrical & Instrumentation/Mechanical Fitter/MAMF Apprenticeship is required. #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 12/06/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years City: Dunboyne State/Province: Meath Country: Ireland Job Description About PSC Biotech Who 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 points, 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 to working in top pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our clients' expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. An amazing opportunity has arisen for a QC Analyst in Analytical Testing in our new state-of-the-art single-use multiproduct Biotech facility. In our start-up site, the role will be responsible for Quality Control testing and all associated laboratory activities related to Biochemistry and Analytical Methods. What you will do: Bring energy, knowledge, innovation, and influence to carry out the following: Perform a variety of routine Analytical techniques and associated documentation, including but not limited to Capillary Electrophoresis, UPLC, HPLC, GC, and Wet Chemistry methods in compliance with GMP requirements. Support activities including general lab readiness, audit readiness, laboratory equipment qualification, and analytical method technical transfer, verification, and validation. Drive the development of technical skills through coaching and motivate a high-performing culture across the team. Foster a continuous improvement environment and bring strong problem-solving and troubleshooting capabilities. Consistently deliver on specific area Key Performance Indicators. Operate to the highest standards of Safety, Quality, and Compliance. Demonstrate a commitment to learning and personal development that supports Quality, EHS, L&D, and continuous improvement. Requirements What skills you will need: In order to excel in this role, you will more than likely have: 1-3 years’ experience in the biotechnology and/or pharmaceutical industry, particularly in relation to Capillary Electrophoresis, UPLC, HPLC, or GC testing. Preferably Lean Six Sigma experience. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Flexible and self-motivated. #J-18808-Ljbffr
Clean Utilities Commissioning and Qualification Engineer Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years City: Dublin State/Province: Dublin Country: Ireland Job Description About PSC Biotech 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 points, 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 to working in top pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through 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. Description: Owns projects and equipment, responsible for document drafting and protocol execution. Overview: Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule and in compliance with GMP and Quality Requirements. Requirements Key Responsibilities: Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation. Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report). Provide technical assistance during investigations and system design. Coordinates and supervises all C&Q activities on their systems. Ensures the C&Q schedule is maintained. Manages daily C&Q coordination meetings. Responsible for tracking and reporting of C&Q status and risks/issues. Ensures startup of equipment/utilities is completed in a safe and coordinated manner. Assist in the development of User Requirement Specifications (URS’s) and Quality. Risk Assessment for Equipment and Automated Systems (QRAES). Education / Experience: 6+ years experience in Engineering or Commissioning and Qualification Management. Technical qualification at third level or equivalent in Engineering. Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical/Biotechnology projects preferred. Knowledge of safety, GMP, and environmental regulatory requirements. Demonstrated strong communication and leadership skills. Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes. Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Familiarity with paperless validation systems. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? 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 Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through 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. Role Description: 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 client’s requirements to ensure compliance, safety and reliable supply to our customers. Requirements Role Functions: 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 machines. Clean room cleaning, housekeeping and materials management in all production areas while focusing on continuous process improvement using Lean Principles. 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. Required to comply with client 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. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills: Core Competencies: Technical: Sterile filling processes and equipment. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Proficiency in Microsoft Office and job related computer applications required. Business: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers. Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one’s department supports. Self-motivated. Flexible approach. Effective time management and multi-tasking skills. Excellent attention to detail. Goal/results orientated. Leadership: Focus on Customers and Patients. Act with Candor and Courage. Make Rapid, Disciplined Decisions. Drive Results. Build Talent. Demonstrate Ethics and Integrity. Qualifications & Education: Typical Minimum Education: Leaving Certificate or equivalent required. Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline. Typical Minimum Experience for this Grade/Level: Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? 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 points, 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 to working in top pharmaceutical client sites in a diverse-cultural work setting. Summary: New opportunity as a QA Specialist for a candidate interested in working in a cGMP regulatory environment. The QA Specialist will be responsible for ensuring that the process for the manufacture of vaccines and biologics and supporting systems are in compliance with cGMP and the associated regulatory requirements. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers. Partner with colleagues cross-functionally/on and off-site to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, systems compliance, etc.; thereby ensuring department/site is audit/inspection ready. Facilitate compliance direction for the site by assisting in the adherence to divisional policies and procedures as well as regulatory requirements. The ideal candidate will have 3-5 years’ experience in a pharmaceutical/regulatory background with strong working knowledge of regulatory expectations, aseptic processing, environmental, and utility monitoring in a sterile manufacturing facility. The role will support quality systems activities and will liaise with the site to ensure systems are maintained and compliant as per global and local procedures. Requirements Bring energy, knowledge, and innovation to carry out the following: Responsible for helping to ensure that the quality systems in use on site maintain complaint status. Act as quality support for the site for relevant systems. Ensure that quality issues are identified, addressed, and resolved in a timely manner. Responsible for supporting issue close out on site and initiating/following up on corrective and preventative actions and continuous improvements. Partner with colleagues cross-functionally to provide support and advice on a day-to-day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, etc. What skills you will need: In order to excel in this role, you will more than likely have: Bachelor Degree or higher preferred; ideally in a related Science discipline. Demonstrated ability in quality systems support. Knowledge of EU/US quality related pharmaceutical regulations. Experience of Sterile manufacture preferred. Ideally a minimum of 3 years’ experience in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in a quality system role. Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices requirements. Knowledgeable in Industry Best Practices for quality and compliance related topics. Proven ability to effectively initiate and drive change. Strong verbal and written communication skills, project management skills. Proficiency in Microsoft Office and job-related computer applications required (electronic validation systems). Ability to work as part of a team to determine priorities. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to drive the completion of tasks. Proven decision-making capability with accountability and responsibility. #J-18808-Ljbffr
Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech 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 points 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 Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through 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. Job Purpose: This role will be part of Manufacturing Self Directed workteam/ Hub in the new state of the art single use multi-product biotech facility in County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists. The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset. Ensure that objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety and provide a reliable supply to our customers. Requirements Responsibilities: Carry out and support operations to achieve assigned duties. Deliver shift standard work for a team-based approach to batch progression. Complete COMMIT cards to highlight ways of working within our SDWT’s and Hubs and across our site that support our COMMIT culture. Conduct sampling/ in-process testing supporting the manufacturing and validation processes. Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT). Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements. Provide coaching to the shift teams on the RFT approach to documentation. Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices. Initiate/ maintain housekeeping in all work areas. Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate. Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc. Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required. Coach and provide oversight on the shop floor to identify potential issues before they arise. Actively participate on cross-functional manufacturing teams to advance projects, goals and deliverables. Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies. Lead straight-through document accuracy metrics and the development of a CI framework. Support site functional initiatives to improve compliance status and operational efficiency of the site. Run handover boards and provide key updates to shift leads for handover. Be escalation point of contact (POC) for troubleshooting, supporting task execution, problem solving, CI projects and assist with the resolution of issues/ delays. Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable. Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of equipment. Effectively manage and schedule equipment shutdowns. Ensure resources are available, thereby minimizing downtime. Any other duties as and when assigned by the Manager. Such as act as a designee for Manufacturing Shift Lead as required. Educational and Experience Requirements: Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices. Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts. Ability to think logically and be proactive under pressure. Excellent troubleshooting and problem-solving skills to coach and mentor the teams through complex problems solving. Technical: On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements. Proficiency with automated systems such as Manufacturing Execution System (MES - PAS X), Systems Applications and Products (SAP), DeltaV etc. Knowledge of Lean methodologies. Familiar with all Safety, GMP, Environmental and Validation permits, policies and procedures. Familiar with plant equipment. Training others and/or leading hands-on or instructor-led training. Ability to read, write and understand technical information. Bachelors Level 8 degree in science, engineering or other technical discipline, or a Level 7 qualification in a science or engineering discipline with a minimum of 5 years’ experience in a GMP regulated environment. 5 years experience in a regulated GMP environment. 3 years experience in Biopharma industry, with direct experience of biologics manufacture would be desirable. Proven record of accomplishments in a regulated industry required. Other Job Requirements: This role is a site based position. This role will involve working shift, on a 24/7 basis. #J-18808-Ljbffr
Tipperary, Ireland | Posted on 08/29/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years Country: Ireland Job Description About PSC Biotech Who we are? 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 points, 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 to working in top pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: The Project Coordinator is coordinating the Suite Leads for the project, managing escalations for schedule, budget, risks, change management, and progress measures. They will also help coordinate all activities in the suite team, including design delivery and documentation, and qualification efforts. Requirements Requirements: Project Management: Lead the Project Suite teams (note: six Suite teams). Manage Suite teams' scope and change control, escalating issues where necessary. Monitor project progress and performance. Partner with EP, CM & CQ and other disciplines on the planning and execution of scope. Provide status reports to the Core team and Project Management. Provide training and mentoring to Suite Team Leads. Ensure all work along with the technical lead is managed in accordance with procedures and best practices. Lead, in collaboration with EP, CM and partners, the cost, risks, change management, and schedule effort for the suite team. Ensure all decision, risk, and action logs are kept up to date. Ensure the Suite Teams are adequately resourced. Resolve cross-functional issues across the suite teams or issues impacting the suite teams. Monitor the performance of the Suite teams (cost, effort, scope, etc.) against the project management plan and performance baseline. Interface with other disciplines & stakeholders to ensure the project meets business needs. Ensure lessons learned, changes, and the impact of changes are captured by all project leads for the project. Experience: Managed projects and sub-project teams on design, installation, and commissioning in the past. Experience in scope, cost, and schedule management. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? 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 points 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 to working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through 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. The Bioprocess Material Associate works within a team of individuals in support of receiving, sampling, dispensing, material supply, and shipping of drug substance at the warehouse and dispensing facility. Requirements Primary Responsibilities: Responsible for Warehouse and/or Dispensing Activities, such as Incoming Goods Receipt, RM Sampling - including RAMAN Spectroscopy testing where required, put-away, RM Dispensing in Grade C, pick for manufacturing, shipping Drug Substance, etc. Provide support to site for the on-site distribution of materials to key internal customers, i.e. manufacturing, labs, MS&T, etc. Extensive use of key warehouse/dispensary equipment, reach truck, VNA, motorized pallet trucks, Downflow Booth, Scales, Drum tippers, etc. Extensive use of COMET (SAP) system to track inventory, MES system within the dispensary operation and LIMS system for sampling operations. Initiate & promote continuous improvements and process improvement within the warehouse/dispensary operations area. Proactively seek opportunities to reduce cost and increase productivity, i.e. reduction in consumable spend, improved scheduling, trusted dispense opportunities, etc. Review and update the Warehouse and Dispensary procedures when required. Qualification and Experience: Ability to work in a cross-functional collaborative environment. Flexible and willing to learn and develop. Technical: Knowledge of and experience in applying Six Sigma and Lean methodologies. Education/Experience: Leaving Cert or equivalent. Level 6 qualification in a related discipline (Preferred but not essential). 1 year experience in warehouse, dispensary, logistics, or manufacturing in the pharmaceutical industry or a similar operating industry. Experienced and trained on reach truck, counterbalance truck, VNA truck, and motorized pallet truck. Experience on use of equipment used in a RM sampling/dispensary operation, i.e. downflow booths, scales, fume hoods, drum movers. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? 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 points 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 Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through 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. Role Description: Responsible for providing process, technical, and validation support to operations for commercial manufacturing and Process Simulation development and execution. Accountable for all studies associated with the development of new components, products, processes systems and facilities in relation to process simulations. Co-ordination, design and execution of commercial & Process simulations studies as required. Requirements Role Functions: Serve as technical support for manufacturing and new product introduction. Design/Author/Review/Approve/Execute process simulations studies in support of new product introduction and ongoing manufacturing support. Provide technical input into quality notification by authoring/reviewing/approving Process Simulation related investigations. Design/Author/Review/Approve/Execute commercial & process simulation qualification/validation documentation and studies in line with the standard approval process. Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis. Support continuous improvement through Lean Six Sigma methodologies. Leading and active participation in projects, system failure investigations and investigation reports. Execution/development of change controls to support the Process Simulation process. Contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; Implement subsequent corrective action through the change management system. Serve as technical engineering representative for internal technical group discussions and represent technical operations at global technical forums in relation to process simulations. Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Drive compliance of client 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, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. Work collaboratively to drive a safe and compliant culture in Client site. May be required to perform other duties as assigned. Core Competences: Technical: Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Equipment and process validation. Sterile filling processes and equipment. Proficiency in Microsoft Office and job related computer applications required. Business: Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team oriented manner. Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one's department supports. Self-motivated. Flexible approach. Effective time management and multi-tasking skills. Excellent attention to detail. Data Analysis. Goal/results oriented. Demonstrable analytical and systematic problem solving skills. Business acumen. Ability to effectively manage complex projects across multiple disciplines. Experience, Knowledge & Skills: Typical Minimum Experience: Experience in an Aseptic sterile manufacturing environment preferred. Demonstrated ability to coach and lead change. Strong Knowledge of Sterile Manufacturing Processes with a focus on delivery and results within highly regulated controlled environment. Qualifications & Education: Typical Minimum Education: Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical Discipline. #J-18808-Ljbffr
