Tipperary, Ireland | Posted on 07/15/2025 Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years Country Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Overview: The role reports to the Payroll Manager, withresponsibilities covering all locations, this role offers location flexibility(remote work available). There is a need to be available onsite as per businessrequirements from time to time. Requirements Responsibilities: Collating and preparing all inputs in advance of payrollprocessing deadlines End-to-end payroll processing in a busy environment ofboth weekly and monthly pay frequencies for multiple assigned entities incompliance with local laws and regulations. Dealing with all aspects of the payroll process, BIK,share awards, pension and other voluntary and statutory deductions. Dealing with starter and leavers registrations Process the monthly PAYE Submissions on ROS Manage the timely response to employee requests andqueries, and escalate when appropriate Complete data validation and data analysis from multiplesources, e.g., HR ERP, T&A, Comp & Benefit providers. Collaborating closely with all relevant parties,including the EMEA HR Service Delivery organization, HR Business Partners, andHR Centers of Excellence. Supporting payroll peers with documentation of payrollsystems, process optimization, and continuous improvement. Participating in projects and working groups. Desired Qualifications & Experience: Bachelor’s degree in Finance, Business or Accounting oranother relevant Payroll qualification; in lieu of a degree 2+ years of Irish Payroll experience with a strongunderstanding of payroll processes, tax, and legal frameworks required. Experience in using payroll systems (CoreHR/People XDportal an advantage) A high degree of attention to detail Enthusiastic and confident with a willingness to workwithin a team environment. Possess the highest degree of integrity andconfidentiality. A flexible approach to work, ability to multi-task,prioritize and execute within deadlines. Customer Focus ensuring that employees payroll experienceremains positive. Self-starter with proven track record of working on owninitiative as well as working with external providers and across organisationalboundaries. #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 07/15/2025 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Dunboyne State/Province Meath Country Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Overview: An amazing opportunity has arisen for a SupportOperations Quality Notifications and Investigations Specialist to provideoperational support for manufacturing operations of our Late Stage and LaunchPipeline products at our new state of the art single use biotechnology facility. Our facility is apremier, state-of-the-art facility that enables and advances our best work. Byintegrating leading-edge technology with a dynamic, activity-based workspace,the facility will support seamless connection and collaboration within andacross teams and functions. Our facility will provide Biologics Drug Substancemanufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in amulti-product mode which requires flexibility to adjust as the pipeline ofclinical and commercial biologics-based medicines demands change. Our facility serves as a magnetic force that attracts,recognizes, and integrates people of diverse backgrounds and perspectives.Employees will feel not only that they belong in the Team , but that thefacility belongs to and is shaped by them. This could be either a 6-month or an 12-month project, depending on the final scope and requirements. Reports to: Drug Substance Support OperationsAssociate Director Requirements Responsibilities: Author Quality Notifications: Take full ownership ofdrafting, reviewing, and finalizing Quality Notifications, ensuring clarity,accuracy, and compliance with regulatory requirements.Initiate and maintain quality relatedmetrics related to Quality Notifications ensuring effective communication andfollow up of the same. Quality Metrics: Ensure that Quality notifications(including CAPAs, Investigations and incidents) meet our metrics for raised ontime and closed on time, while maintaining a high standard of technical writingand compliance. Incident Reporting: Solely manage the authoring ofincident reports, documenting quality issues and ensuring timely submission forreview and approval. Investigations Documentation: Lead the authoring ofcomprehensive investigation reports, detailing findings, root cause analyses,and corrective actions. Approval Process Management: Navigate the approvalprocess for all authored documents, collaborating with cross-functional teamsto ensure timely reviews and compliance with quality management systems. Quality Risk Assessments: Participate in Quality RiskAssessments as needed, providing insights and documentation to support theevaluation of quality risks. Continuous Improvement: Contribute to a culture ofcontinuous improvement by identifying opportunities for enhancing documentationprocesses and quality practices. Compliance Adherence: Ensure all authored documents meetthe necessary compliance standards and are aligned with the ManufacturingDivision Quality Management Systems (QMS). Training and Support: Provide guidance to team members onbest practices for documentation and compliance, fostering a culture of qualityawareness Skills & Education: Bachelor’s degree in Biotechnology, Chemistry, Biology,Pharmacy, or Process engineering. 2 years + experience in Biotech Industry (bulkmanufacturing of pharmaceutical or biological components). Position level will scale withexperience level of candidate. Strong technical writing capability and previousexperience authoring reports and investigations in a GMP environment Competent in analysing complex situations and showpractical problem-solving capabilities. Ability to work independently and within across-functional team. Preferred Skills: Experience in leading and facilitating Root CauseAnalysis and Quality Risk Assessment sessions Experience supporting Regulatory Inspections and SiteInternal Audits UnderstandingofUpstream and Downstream Unit Operations for mAb manufacturing #J-18808-Ljbffr
Cork city, Ireland | Posted on 07/16/2025 Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Cork city State/Province Cork Country Ireland Job Description The CSV Engineer – SAP Systems will be responsible for delivering and maintaining compliant, validated SAP environments that meet regulatory and operational expectations. This role ensures computerised systems supporting manufacturing, quality, and supply chain are validated and maintained in accordance with GxP , FDA 21 CFR Part 11 , and EU Annex 11 requirements. Key Responsibilities Lead and support Computer System Validation (CSV) activities for SAP modules (e.g., MM, QM, PP, SD, WM, PM). Author and execute validation documentation including Risk Assessments, URS, IQ/OQ/PQ , and traceability matrices. Ensure validation activities comply with GAMP 5 and internal procedures. Collaborate with cross-functional teams: Quality, IT, Engineering, Manufacturing, and external vendors. Support change management and periodic review processes for validated systems. Participate in audits and inspections; represent CSV/SAP validation scope. Maintain system lifecycle documentation and ensure ongoing compliance post-deployment. Requirements Required Qualifications & Experience Bachelor’s degree in Engineering, Computer Science, Life Sciences , or related discipline. 3–5 years’ experience in a CSV role within a pharmaceutical or biotech GMP environment. Hands-on experience validating SAP ECC or S/4HANA in a GxP-regulated context. Strong understanding of CSV lifecycle , GAMP 5, 21 CFR Part 11, and EU Annex 11. Excellent documentation, organisational, and communication skills #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 07/15/2025 Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years City: Dunboyne State/Province: Meath Country: Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients across more than 23 countries, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing, and metrology services. Career Opportunity Join our team as a Qualified Person in our state-of-the-art Biologics facility in Ireland. This role offers the chance to work with cutting-edge technology and be part of a dynamic, collaborative environment in the biotech industry. Requirements Role Functions: Perform Qualified Person (QP) duties, certifying batches for release per EC directives including 2001/83/EC, Annex 16, and Annex 13. Ensure manufacturing and testing comply with cGMP and relevant regulations. Manage deviations and investigations related to drug substance manufacture and testing. Review and approve change requests impacting product quality and compliance. Experience, Knowledge & Skills: At least 5 years of EU QP experience certifying batches according to EU directives. Comprehensive knowledge of GMPs, regulations, and industry trends. Strong communication, decision-making, and project management skills. Qualifications & Education: EU QP qualification with minimum 5 years of relevant experience. BSc or higher in Biotechnology, Chemistry, Biology, or related field. #J-18808-Ljbffr
Drug Process Operations Specialist-Shift Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met. Overview: An amazing opportunity has arisen for a ProcessOperations Specialist , to provide operational support for manufacturingoperations of Late Stage and Launch Pipeline products at our new state of theart single use biotechnology facility in Dunboyne, Ireland. Reports to: Drug Substance Process Operations Lead Shift Pattern: 24/7 shift Requirements Responsibilities: Reporting to the Process Operations Lead the OperationsSpecialist will support end-to end production operations for both Fed Batch andContinuous Manufacturing Lead/Guide team members within the Production Operationsteam Coach and develop colleagues within the Production team Support team on shift cycle and act as POC (point ofcontact) and POE (point of escalation) to ensure effective issue resolution Lead, facilitate and participate in cross-functionalteams to collaborate effectively to cover compliance topics. Responsible for monitoring operational performance,follow-up on any significant adverse trends for the identification andimplementation of operational optimization, and robustness improvementprojects. Ability to solve problems and take new perspectives onexisting solutions with a desire to continuously learn, improve and develop. A Change and QRA Champion within the organization andsite, to bring about new technologies, digitization, and identify opportunitiesto bring new ways of working. Lead complex process investigations on the productionfloor in support of deviation resolution. Use the extensive operational experience to mentor newmembers of staff in specific plant activities when required and as a key pointof contact for external groups Support team on 24/7 shift cycle and act as POC (point ofcontact) and POE (point of escalation) to ensure issue resolution Conduct all work activities with a strict adherence tothe safety and compliance culture on site Participate in safety, process and environmentalinvestigations. Review alert and action limits as needed and implementcorrective action as appropriate Write, review, and/or approve manufacturing documentation(SOPs, Manufacturing Records & Logbooks) Ensure the effective use of material, equipment andpersonnel in producing quality products. Required Education, Experience and Skills: Bachelor’s degree in Biotechnology, Chemistry, Biology,Pharmacy, or Process engineering. 4 years + experience in Biotech Industry (bulkmanufacturing of pharmaceutical or biological components). Position level will scale withexperience level of candidate. Competent in analyzing complex situations and showpractical problem-solving capabilities. Ability to work independently and within across-functional team. Understanding of multi column chromatography concepts Familiarity with contamination control and batch releaserequirements Experience leading, presenting, or supporting RegulatoryInspections and Site Internal Audits Problem, Deviation, and Change Management experience Preferred Experience and Skills: Commissioning and Qualification experience Understanding of Upstream and Downstream Unit Operationsfor mAb manufacturing Familiarity with Emerson DeltaV, SIPAT,and the use of Automation in amanufacturing Process. #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. We serve 350 clients across more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing, and metrology services. Take your Career to a new Level PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition (EVP), including opportunities to work with talented professionals in the Pharma/Biotech industry. We provide permanent employment contracts, offering exposure to top pharmaceutical client sites in diverse cultural settings. Employee Value Proposition Our employees are the heartbeat of PSC Biotech. We support their career development through in-house training, mentorship, and guidance to facilitate growth. We aim to create high-performing teams that exceed client expectations regarding quality, budget, and timelines. Overview We are seeking an experienced Project Manager to join our PMO (Project Management Office). This key role supports project delivery excellence and involves leading and governing cross-functional projects on-site. Responsibilities Manage selected projects within the site’s project portfolio, including process improvements, new system deliveries, and NPI projects in drug products. Lead or support rapid improvement projects using appropriate methodologies (Waterfall, Agile, Scrum). Work with project sponsors at initiation to define and understand project scope. Partner with cross-functional teams to ensure project execution aligns with plans. Resolve issues and escalate risks promptly to stakeholders. Experience & Qualifications Minimum of 6+ years industry experience, with at least 4 years in a project management role. Experience with project execution methodologies (Waterfall, Agile, Scrum). Proficiency in project management tools/software. Experience leading cross-functional matrix teams. Operational Excellence Green Belt certification preferred. Bachelor’s degree in Operations Management, Engineering, Science, or related field. Pharmaceutical industry experience, specifically in vaccines, biologics, or sterile manufacturing environments. #J-18808-Ljbffr
Senior Manufacturing Bioprocess Associate - Drug Substance Process Operations Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 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 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: By integrating leading-edge technology with a dynamic, activity-based workspace, the facility will support seamless connection and collaboration within and across teams and functions. The facility will provide Biologics Drug Substance manufacturing for Clinical Supply, Registration & Commercial Launch. The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change. An amazing opportunity has arisen for a Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at our new state-of-the-art single-use biotechnology facility in Ireland. This role will involve supporting manufacturing operations on a Shift Rotation basis. The facility serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Reports to: Drug Substance Process Operations Manager Requirements Role Functions: The Senior Manufacturing Bioprocess Associate will support end-to-end production operations for both Fed Batch and Continuous Manufacturing. Support on-floor manufacturing of pipeline products. Operate equipment according to electronic batch records, sampling plans, and standard operating procedures. Shift role 24/7 (Onsite). Work as part of a dedicated process team where flexibility and teamwork are key requirements. Ability to solve problems with a desire to continuously learn, improve and develop. Conduct all work activities with strict adherence to the safety and compliance culture on site. Support the authoring of electronic batch records, sampling plans, work instructions, and standard operating procedures. Skills and Education: A level 6 with a minimum of 3+ years’ experience in a GMP Manufacturing requirement shall be deemed equivalent. Competent in troubleshooting and show practical problem-solving capabilities. Ability to work independently and within a cross-functional team. Familiarity with contamination control and batch release requirements. Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process. Proficiency in various Single-Use technologies in a manufacturing environment. Preferred Experience: Commissioning and Qualification experience. Understanding of Upstream and Downstream Unit Operations for mAb manufacturing. Understanding of both continuous and batch fed manufacturing processes. #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 05/14/2025 Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ 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. We serve 350 clients across more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, including the opportunity to work with talented professionals in the Pharma/Biotech industry. We provide permanent contracts, exposing employees to top pharmaceutical client sites in diverse cultural settings. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech. We offer empowering career development through in-house training, mentorship, and ongoing guidance to facilitate career progression. We focus on creating high-performing teams that exceed client expectations in quality, budget, and timelines. Overview: The QAV / DDQ Specialist will oversee Digital Data Quality and Validation activities at the client facility. This role is a key part of the quality assurance team, ensuring operational compliance with cGMP regulations. The role requires maintaining cGMP standards in accordance with policies, procedures, and regulatory requirements, with experience within an FDA/EMEA regulated environment. Requirements Key Accountabilities: Lead and participate in cross-functional teams to address compliance issues and achieve project milestones. Participate in investigations, risk assessments, and ensure timely implementation of actions. Contribute to all project phases, including design, procurement, construction, start-up, and validation. Review and approve Change Controls, Deviations, CAPAs, SOPs, and related documents for GMP compliance. Oversee qualification/validation, technical transfers, regulatory approvals, and operations. Review validation lifecycle documents and reports. Provide QA oversight of computer system validation activities following validation plans and GMP standards. Assess new regulatory guidance and industry best practices, updating systems accordingly. Assist in creating and maintaining QA policies, SOPs, and reports. Support continuous improvement initiatives. Participate in risk management activities and internal audits. Foster strong relationships with management and colleagues to promote a compliant culture. Escalate compliance risks promptly. Perform additional tasks as assigned by the Associate Director of QA Validation. Educational and Experience Requirements: Postgraduate qualification in engineering or science (advantageous). Minimum 5 years’ experience in Quality Assurance/Validation in the biological/pharmaceutical industry, including computer systems validation. Experience with commissioning and validation of computerized systems and process equipment. Knowledge of GAMP requirements is a plus. Experience supporting complex investigations and problem-solving. Project management skills with knowledge of Power BI. Experience with QRM, investigations, and problem-solving as a Quality SME. Strong communication skills. Logical thinking and proactive under pressure. Ability to work independently and in teams. Attention to detail in GMP documentation. Experience with quality management systems like VeevaVault, SAP, Trackwise, KNEAT. Knowledge of FDA, HPRA, EMEA regulations related to biologics and pharmaceuticals. Experience with regulatory agency interactions during inspections. #J-18808-Ljbffr
