Dunboyne, Ireland | Posted on 11/29/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years City: Dunboyne 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 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. Requirements Responsibilities: Support laboratory operations within the new laboratory facility, including support of equipment qualification (PQ), documentation generation of SOPs, and work instructions, as well as contributing to lab and process establishment. Review, trending, and reporting of laboratory data to support generation of batch data, maintain oversight of review metrics, and collate and analyze end-of-quarter and year reports for all raw data generated. Maintain and release laboratory stock, ordering laboratory consumables where required. Manage and ensure routine cleans of laboratory equipment are completed as per site procedures, ensure laboratory housekeeping standards are maintained, and identify continuous improvement opportunities in laboratory processes. Respond to standard requests from partners, customers, and clients (internal and/or external). Active participation in functional meetings, facilitating cross-functional meetings where required. Participate in laboratory investigations and Root Cause Analysis activities. Participate in internal and external audit and inspection activities. Participate in SME development groups to improve technical expertise. Support site safety culture. Perform supporting activities for general lab operations, EM, facility testing, method transfers, method verifications, and execution of laboratory studies where required. Demonstrate a good knowledge of GMP, familiarity with USP, EP, and JP requirements. Support the introduction of novel, innovative solutions, supporting the testing of biologics within the facility. Participate in risk assessments as required. Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve, and develop. Excellent troubleshooting and problem-solving skills as an individual contributor as well as collaboration skills and team working ability with global and interdisciplinary teams. Support the culture of the client's ways of working. Build team effectiveness skills, learn to promote team success through own actions, and demonstrate respect and appreciation for diverse populations. Support timely training completion and coaching of team members. Be flexible to support changing business needs (e.g., infrequent out-of-hours testing support for exceptional circumstances). Act as a group representative at cross-functional meetings. Experience, Knowledge & Skills: Ability to work as part of a team and on own initiative in a constructive manner. Knowledge of biologics manufacturing and familiarity with microbiological testing techniques. Knowledge of laboratory systems (e.g., LIMS, E-logs, MODA, and electronic notebooks). Ability to think logically and be proactive under pressure. Effective communicator and technical expertise in science, able to share and communicate that knowledge through training other analysts. Qualification: A degree qualification in a relevant field (Biological Sciences/Engineering), preferably with a background in microbiology. A minimum of 1-3 years experience working in a relevant academic or industry field (internships and student placements will be considered in lieu of experience). #J-18808-Ljbffr
Tipperary, Ireland | Posted on 11/29/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years 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, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met. Overview: The SIS Co-ordinator operates in a team-based, continuous improvement environment within the Engineering CoE (Centre of Excellence) and works closely with colleagues from Projects, Automation & IT, Operations, and Maintenance EHS with support from external SME resources to implement improvements to the IEC-61508/IEC-61511 aligned Functional Safety Management System. The SIS Co-ordinator will be the custodian of the Functional Safety Management System at the site. Training and support shall be provided with the role. Requirements Responsibilities: Act as custodian of the Functional Safety Management System at our site. Implement new & revise existing SOPs, Job Aids, Work Instructions, and documentation for our Functional Safety Management System, making use of systems already established. Support Functional Safety Life Cycle activities such as: Attending HAZOPs and LOPAs where interlocks designed to IEC-61508/IEC-61511 (SISs) are anticipated. Provide guidance for SIS Operation, Maintenance & testing best practices. Verification activities. Organizing periodic FSAs (Functional Safety Assessments) and External Functional Safety Audits. Organizing training programs for Functional Safety Management. Provide status reports to Management. Support other Site Engineering Systems where there are synergies & capacity allows. Skills & Education Required: Bachelor's Degree or equivalent in a relevant Engineering or other Technical discipline or a Trade/3rd level qualification in a related discipline with experience working in a similar environment. Preferably 3 years or more experience working in a similar role or a related discipline (Engineering, Calibration, and Instrumentation), preferably in a process plant GMP environment with a strong compliance mindset. Experienced in managing Engineering or Maintenance programmes. Potential candidates may have some familiarity with electrical & instrumentation operation, maintenance & testing principles along with some understanding of the automation systems they interface with in a processing plant. TUV Rheinland or equivalent Certification in Functional Safety is desirable. Otherwise, knowledge and certification for basic Functional Safety is advised. In any case, training and certification will be provided for the successful applicant along with access to support from internal and external SME resources. Familiarity with IEC61511 and IEC61508 is desirable. Analytical mindset, data-driven with attention to detail on systems and technical documentation. Some knowledge of ATEX principles/working in an ATEX plant environment is desirable. Good communication skills, decision-making, and problem-solving skills with a proven track record for effectively collaborating, influencing, and working well within a cross-functional team. Reporting to: API Reliability & Systems Lead #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 include 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. Senior Specialist in Analytical Science Job Purpose: The Sr Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site, particularly Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing, and Quality Control, acting as Analytical Method and PAT SME while taking a lead in utilizing the latest innovations in technology and automation to create a workplace of the future. Requirements Primary Responsibilities: Serving as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching to associate staff. Provide technical leadership for experimental design, execution, data analysis, and interpretation. Development, transfer, and qualification of assays. Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc). Technical point of contact for Process Analytical Technologies (PAT). Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions. Technical lead for characterization testing, ensuring testing conducted either internally or externally. Serving as a key member during internal audits and external inspections/audits. Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with an end-to-end product focus. Qualification and Experience: Demonstrated leadership and change management skills with a continuous improvement focus. A self-starter and results-focused, with strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science to drive decision making, impact assessments, and design of studies in a multi-disciplinary team environment. With a Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry, the successful candidate will ideally have a proven track record in delivering excellence. Technical: Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules. Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus. Significant amount of Analytical Chromatography experience, ideally with some Mass Spectrometry experience. Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organizations for development and/or manufacturing. Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software). Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes. This role requires an experienced individual with a minimum of 6 years’ (for MSc), 8 years’ (for BSc) directly related experience in academia, pharmaceutical or biotechnology company – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. Experience with assay development and qualification of biologics assays (HPLC-based, ELISA, etc). Familiarity with potency assays, including cell-based assays. #J-18808-Ljbffr
Tipperary, Ireland | Posted on 11/29/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years 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. Overview: An amazing opportunity has arisen for a Laboratory-based Instrument Specialist. With ultra-modern manufacturing facilities, we are one of the largest and most successful healthcare companies in the world specializing in the development, manufacture, and distribution of a broad range of innovative products designed to improve human health. The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up-to-date technology and quality assurance procedures. The laboratory operates under Lean principles and employs the use of a wide variety of analytical techniques. Requirements Responsibilities: Maintain Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures, and guidelines. Review instrument calibrations to ensure uptime for all instruments supporting testing activities. Provide a preventative maintenance service to ensure functionality and a calibration service to maintain the instruments according to their working specifications. Ensure that all instruments are maintained in a validated state through a PM/PV schedule and ensure that this schedule is adhered to by the Instrument group and contract vendors. Be part of a dynamic team responsible for Data Integrity requirements for all computerized and non-computerized systems across all the laboratories. Skills Required: Applications are invited from candidates who have a degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience. Knowledge of GMP standards. Knowledge of Laboratory safety standards. Good communication skills, both written and verbal. Strong documentation skills are required. Must be motivated, focused, and technically strong. Maintain accurate records in compliance with GMP expectations. Understand and internalize procedures relevant to GMP operations. #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 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 responsible for 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. This includes design delivery and documentation, as well as 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
Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years City: Dublin State/Province: Dublin 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 include 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. Indirect Tax Specialist Overview: Working as part of a Global Tax organisation, the Indirect Tax Specialist will assist the Global Indirect Tax Compliance leads to support the various indirect tax activities of the company globally. This will involve assisting in managing the efforts to ensure that the organisation is compliant with all indirect tax laws, all filings are correct and on time, that all processes are documented, and all indirect tax matters are resolved timely, thereby reducing the tax burden to the organization. This position requires demonstrable indirect tax knowledge, analytical abilities, communication skills, and will be responsible for assisting in various facets of the Global Indirect Tax process, including review of master data, transactional inputs, system design and controls. This role will suit a quick learner who can adapt and perform in the role shortly after recruitment and bring fresh ideas to an established Indirect Tax compliance process. Requirements Work Model: Hybrid Responsibilities: Prepare and review Indirect Tax returns for multiple EMEA jurisdictions. Ensure VAT SOX and internal audit controls are adhered to. Act as key liaison between indirect tax and non-tax departments to raise VAT compliance profile, remedy tax issues at source and proactively manage risk. Actively monitor tax process and systems to ensure that they are efficient, accurate, up to date and comply with current regulatory requirements. Identify and communicate opportunities to achieve end-to-end process improvements and coordinate implementation as needed. Keep abreast of changes to Indirect Tax legislation and potential impact on the company. Education: Bachelor’s degree in accounting or finance. Minimum of 3 years of experience in a MNC tax function related to indirect taxes. EMEA VAT Specialisation. Fluent English required; other language an advantage. Track record demonstrating high standard of communication, interpersonal, and organisational skills required. Problem solving and analytical skills with a proactive and collaborative mindset. Ability to work independently, capable of handling multiple projects and deadlines simultaneously. History of successful role and process optimisation results. Skills: Microsoft Office, Ariba, SAP experience with tax determination software an advantage. Tax Determination (Sabrix, Vertex) experience preferred. Comfortable in a high volume, deadline-driven environment with emphasis on attention to detail and accuracy. Willingness to generate and share ideas with a continuous improvement focus. Ability to operate independently, within a team and navigate through change or uncertainty. Demonstrate flexibility in working roles and assisting colleagues in busy periods by proactively offering support when required. Reports To: Indirect Tax Manager #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 11/22/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years City: Dunboyne 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 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 quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met. Overview: This role will be part of the Manufacturing Self-Directed Work Team/Hub in our new state-of-the-art single-use multi-product biotech facility. The organizational structure at the site will be based on self-directed work teams (SDWT) where decisions will be made at the level where the data exists. The BTA is responsible for all procedures and processes associated with the manufacture of Drug Substance at the manufacturing facility, at the highest standards of Safety, Quality, and Compliance. The BTA will be responsible for undertaking manufacturing operations involved in the production of biologic drug substance on their designated shift. Key responsibilities include the execution of an automated recipe using paperless technology to progress the drug substance through inoculation and cell culturing activities, leading to filtration and purification of the product in a state-of-the-art single-use technology-based facility. The incumbent will be involved in setting up the single-use equipment between runs, carrying out the production process according to world-class GMP and EHS principles. The BTA will also be involved in driving to optimize and improve the processing activities through the use of standard work and lean processing techniques while supporting the operations team to consistently deliver on specific Key Performance Indicators (KPIs). At all times, this role is focused on delivery to the patient through living the culture, including a commitment to safety, focusing on right first time in everything we do, and concentrating on the engagement and development of self and peers. This role is site-based and will involve working shifts on a 24/7 basis. Requirements Responsibilities: Participate in internal audit programs and risk assessment compliance activity. Coach shift teams related to RFT documentation. Lead by example through coaching and mentoring on Production systems skill transfer. Coach CAPAs, Change actions/SOP updates, training module development/revision related to cell area. Utilize real-time data analytics for making decisions on value stream improvement initiatives. Troubleshoot and resolve issues and delays. Lead and participate in investigations arising from manufacturing documentation aspects when required. Promote EHS leadership behaviors and engage employees at all levels on EHS issues. Promote an environment where everyone speaks up for our culture of safety and looks out for one another. Confirm that all activities have been correctly completed by the end of the shift, such as Real-time batch record/SAP Comet review and e-logs review. Be a visible leader of safety initiatives and stay actively involved in safety forums. Act as a Cell Lead and be responsible for a unit operation. Any other duties as assigned by the Manager. Skills & Education: Ability to interact with multiple stakeholders across numerous departments. Ability to manage multiple priorities and know when to escalate issues for resolution. Excellent troubleshooting skills as well as an ability to coach and mentor self-directed teams through complex problem-solving. Level 7 qualification in a science or engineering discipline, or Level 6 with a minimum of 1-3 years’ experience in a GMP regulated Manufacturing environment. Experience of Upstream/Downstream Processing. Experience in a highly regulated pharmaceutical manufacturing environment would be desirable. Proven record of accomplishments in a regulated industry. Start-up experience in a large-scale commercial drug substance facility, or similar. #J-18808-Ljbffr
Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years City: Carlow State/Province: Carlow 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. Overview: As part of the SCM team, perform various weigh and dispense and material availability-related tasks to aid in the manufacture and reliable supply of products. Ensure that objectives are effectively achieved and consistent with client’s requirements to ensure compliance, safety, and reliable supply to our customers. Requirements Role Functions: Operate and/or monitor weigh and dispense 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, down flow booth and scales. Cleanroom cleaning, housekeeping, and materials management in the Weigh and Dispense area. Ensure material availability to support operations. Pick materials from stored locations in a GMP compliance managed location and transport the materials to the production area in accordance with the SOPs and GMP stated standards of performance. Move materials from the production area to the warehouse or any other location facility in compliance with the site SOPs and GMP standards. Follow direction and instruction regarding the movement of material from delivery vehicles to the client facility and also dispatch of materials from the client facility. Work in a safe manner regarding the lifting and movement of materials. Pack out materials and consume to order to simplify processes for IPT (future state). Check calibration of equipment ensuring the calibration is up to date. Using the EBR to dispense materials in weigh & dispense. Manage equipment flow, including tracking soiled and clean hold times, proper labeling, and inventory management of clean and sterile equipment using automated MES system. 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 Weigh and Dispense processes and material management; 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/QNs, and contribution to projects as appropriate. 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 business requires. Experience, Knowledge & Skills: Would typically have prior related work experience, ideally in a cleanroom environment, preferably in a GMP setting. Knowledge of MES & SAP is desirable but not essential. Forklift experience is desirable. Qualifications & Education: Leaving Certificate or equivalent required. Apprenticeship, Certificate or Diploma preferred, ideally in a related discipline. #J-18808-Ljbffr
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, and we provide unparalleled empowering career development through Learning & Development in-house training and 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: A fantastic opportunity has arisen for a Senior Procurement Specialist. As a Senior Specialist in Global Sourcing, you will ensure that procedures and processes are securely established to support the current operating plans for the manufacturing site. Key categories include IFM/Utilities, MRO, Laboratory and Automation, IT and Business services, Direct materials/components, and Capital Equipment. You will collaborate with senior functional and operational stakeholders to develop and execute global supply and sourcing strategies. In this position, you will support the Manufacturing Division's strategic imperatives and will enable core elements of strategy: stability, responsiveness, building capacity, and fostering innovation. You will be responsible for planning and conducting negotiations as well as leading and conducting RFx for goods and services in scope. Requirements Responsibilities: Manages direct, indirect, and research procurement categories including strategic sourcing and procurement, supplier negotiations, and contract development & management. Relationship management with senior stakeholders on-site in order to provide full support on supply, driving & supporting changes, understanding site priorities, and at the same time using that opportunity to seek support & alignment on implementing procurement-driven projects (supplier changes, commercial initiatives, etc.) Strategic supplier relationship management to drive alignment to Category targets and to enable continuous improvement (supply, quality, innovation, cost, and regulatory aspects) Implementation of globally cascaded projects (enabling global suppliers, driving global category strategy, etc.) including project management to meet project deadlines, alignment with the site, managing supplier transition, etc. Responsible for continuous procurement process improvement, increasing personal productivity. Engages, obtains sponsorship, and influences senior-level stakeholders/demonstrates procurement value proposition, creates a delivery plan shared jointly with business stakeholders. Develops end-to-end risk management strategies and performance management & improvement strategies. Acts as a change agent, demonstrating added value brought by the procurement function. Is a personal example and role model of the leadership behaviors. Actively supports diversity within the company as well as expanding relationships with diverse, SME suppliers. Responsible for developing and delivering objectives and targets in respective categories including savings forecast, working capital conversion/pull-through targets, SME (Small and Medium Enterprises) spend targets, spend concentration %, and contract compliance % targets. Skills & Qualification Required: BS/BA degree in Engineering/Supply Chain or Business minimally; MBA or CPM/supply chain certification preferred. Working experience in multinational companies, complex matrix organizations, with exposure to international teams. 5-7 years of experience in manufacturing/supply chain/procurement for manufacturing sites. 3 to 5 years of procurement experience, including setting up and managing supplier contracts. Demonstrates strong leadership, collaboration, problem-solving, and conflict management skills. Drives results while dealing with ambiguity and complex environments. Excellent oral and written communication skills. Able to influence at all levels in the organization. Demonstrates capabilities in Strategic stakeholder relationship management, Supplier relationship management, Project management, Cost optimization, Negotiations and Contract management, Financial/Legal/Business acumen. #J-18808-Ljbffr
Tipperary, Ireland | Posted on 11/15/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years 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. Overview: Exciting opportunity for an experienced Project Engineer. Join our dynamic Site Projects Group as a Project Engineer and support site Capital & Expense projects. As the Project Engineer, you will report to the Site Projects Lead and play a crucial role in driving project success within our site portfolio of projects. We are seeking a passionate individual with the experience, dedication, and excellent communication skills to excel in this role. Requirements Key Responsibilities: Develop and execute project plans to meet established schedule, cost, and performance standards. Manage design, commissioning, qualification, schedule, and cost in collaboration with project team members, operations personnel, contractors, and suppliers. Track and report project progress against deliverables as required. Work collaboratively to promote a safe and compliant culture on site. Ensure timely and within-budget delivery of projects and assigned duties. Manage multiple capital project executions in parallel, ensuring high-quality results meeting company standards. Oversee site construction activities, particularly during busy periods and annual leave periods. Qualifications and Skills: Engineering qualification, preferably in Chemical, Mechanical, Electrical, or Project Management disciplines. At least 5 years of relevant experience in the Pharmaceutical/Biopharmaceutical industry, with expertise in maintenance, engineering, and project management. Experience with SAP is preferred, but not essential. Understanding of the project life cycle from concept to qualification, with proven experience in this area. Ability to work independently and as part of a team, with familiarity in engineering project management tools and financial management. Commitment to the highest engineering standards, with strong technical and problem-solving skills. Knowledge, appreciation, and experience of working in a strongly regulated GMP environment. Exceptional interpersonal, communication, presentation, organizational, planning, and negotiation skills. Familiar with engineering project management tools, financial management skills including an ability to work within budgets, engineering technical skills. #J-18808-Ljbffr
