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 Employee Value Proposition as one of our 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, providing exposure to top pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech. We provide unparalleled career development through in-house training, mentorship, and constant guidance to facilitate career progression. We aim to create high-performing teams that exceed our client’s expectations regarding quality, staying under budget, and meeting project timelines. Overview: The Mechanical Technician will be responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing. You will ensure objectives are achieved effectively, in compliance with company requirements to ensure safety and reliable supply to our customers. Reporting to: Maintenance Lead Shift Pattern: Days initially, moving to 2-cycle shifts (7 am-3 pm, 3 pm-11 pm) Requirements Responsibilities: Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation, and modification; perform detailed maintenance, calibrations, PMs, and troubleshooting. (MAMF Qualified) Operate and clean process equipment as necessary. Maintain process and production equipment, ensuring ongoing preventative maintenance, troubleshooting, and repairs for continuous, reliable operation; drive Total Productive Maintenance. Manage equipment shutdown scheduling, ensuring resource availability to minimize downtime. Support maintenance planning and preventive maintenance through completion of work orders, calibrations, and PMs. Document maintenance work, upgrades, and parts used to ensure proper records of repair history. Operate and monitor production support equipment using MES/DCS and PLC systems to ensure optimal uptime and outputs, and facilitate continuous process improvements using Lean principles. Operate, troubleshoot, and repair complex systems including autoclaves, glassware washers, single-use mixers, HVAC, isolators, filling lines, and inspection lines under minimal supervision in a cGMP environment. Interpret P&ID’s, equipment layouts, wiring diagrams, and specifications for maintenance and repairs. Support continuous improvement initiatives, including repairs, upgrades, system failure investigations, change control, and Kaizen events. Perform root cause analysis of system failures using tools like FMEA, Fishbone diagrams, and 5 Whys; implement corrective actions through change management. Provide technical data for spare parts and asset entry into CMMS; liaise with vendors for parts and system upgrades. Assist in facility upkeep and provide responsive customer support. Participate in writing, revising, and implementing operational procedures, training materials, and maintenance procedures. Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards. Promote a safe and compliant work culture. Perform other duties as assigned. Skills Required: Serviced MAMF Apprenticeship or equivalent Certificate/Diploma in Engineering or related discipline. Prior experience in a cGMP-regulated pharmaceutical environment. Extensive hands-on experience in preventive/reactive maintenance. Understanding of mechanical, electrical, instrumentation, and pneumatic processes. Proficiency in Microsoft Office and other job-related applications, with excellent technical communication skills. #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 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. 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 regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: The Quality Control (QC) Systems Specialist at the facility will support the QC Laboratory through routine maintenance, troubleshooting, and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle as a whole (installation, qualification, operation, and retirement). The QC Systems Specialist leads continuous improvement of QC operations through their QC Systems knowledge and areas of expertise. The QC Lab System team at the facility will ensure that QC objectives are effectively achieved and consistent with the facility requirements to ensure compliance, safety, and reliable supply to our customers. Requirements Responsibilities: The QC Maintenance Instrumentation Specialist roles and responsibilities include but are not limited to the following: Responsible for the maintenance of the QC systems and instrumentation, in compliance with up-to-date data integrity, regulatory, and industry standards. Responsible for change control process and mechanisms required to maintain a state of continued compliance for the QC systems and instrumentation. Support the QC department for troubleshooting, investigations, and deviations as an SME. Manage deviations, CAPAs, and change controls related to QC systems and instrumentation and team priorities. Author and revise local SOPs, work instructions, and guidelines. Serve as an SME for regulatory and internal inspections and audits. Motivation to be an inspiring member of a high performing team with the desire to continuously learn, improve, and develop. Experience, Knowledge & Skills: Technical: Strong experience with analytical instrument maintenance; CSV experience beneficial. Excellent understanding of data integrity compliance requirements. Demonstrated ability to drive complex tasks to completion. Strong organizational, problem-solving, and continuous improvement skills. Business: Ability to prioritize activities in line with the maintenance schedules and business needs. Ability to maintain the flexibility to react to changing business needs. Experience and understanding of the change management requirements of validated systems and software. Excellent communication skills, both verbal and written. Leadership: Ability to handle multiple projects and deliver on critical deadlines. Demonstrated ability to work independently on own initiative and manage time. Demonstrate ability to work with a team and coordinate work to meet a common goal. A high level of self-motivation, knowledge, enthusiasm, and drive. Qualifications: Third level education in a Science or Engineering related course of study. #J-18808-Ljbffr

Industry Pharma/Biotech/Clinical Research Work Experience 5+ 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 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. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, and 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 regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are met. Overview: An exciting opportunity has come to join the science, engineering/manufacturing & commercialisation team to support the transition of the facility from construction & project phase to a commercialisation of a fully operational facility delivering life-saving products to patients. Requirements Responsibilities: Vial and Syringe Sterile operations – Isolators, VHP, decontamination systems. Cleaning Validation in Biotech facility & Cleaning Processes Single Use Technologies – SUT and SU components/manifolds Filter Validation – Sterilising and Bioburden reducing Filter Validation & Process Validation Ancillary Equipment for Bio-processing – Tube Welders/Sealers/ Filter Integrity / Glove Integrity Testing Formulation processing using DeltaV including Transfer Panel and Utility Qualification. Parenteral Product Visual Inspection (Automated Inspection). High Potency and ICH Q5 products & containment methodologies. The successful candidate should have demonstrated experience in at least 2 of these key areas and alongside new facility introduction experience. The successful candidate will be involved in the project from Operational Qualification (OQ) through to the Equipment Performance Qualification, Validation and Product PQ – including filing with regulatory bodies. Levels of responsibility will vary during this timeframe as outlined below – Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on; Aligning new facility introduction with Validation approach across site and review and approval of project VMP CQV approver for C&Q documents and input to Validation strategy documents and project plans and procedures Acting as Validation SME within a team of site representatives as system owner for PQ/Validation Site Acceptance Test – Attendance, hands-on support and C&Q Oversight for assigned process equipment. Working with the C&Q Lead to ensure a consolidated & compliant approach to C&Q and readiness for CQV crossover into right-first-time Validation/PQ executions. Commissioning & Qualification – Hands-on support & Oversight for assigned process equipment. Cycle Development – Execution of Cycle Development pre and post OQ phases for assigned process equipment. Performance Qualification – Responsibility for /Execution of Performance Qualification testing for assigned process equipment. Liaising with Tech Transfer team to ensure product requirements are met. Ownership of updates to Technical SOPs related to Validation and assigned process systems. Managing site change controls as part of QMS implementation of the new facility as required. Ensuring that PQ and Validation are aligned with the regulatory & market requirements for filing the new facility and product licensure at the close out of the project. Role Functions: Within the role you will be acting as a technical SME & Senior CQ/Validation Engineer reporting within Technical Engineering at Tier 1 and Tier 2 level as required. Work within a team of Validation professionals from ‘Intern’ level to Associate Director to own and execute the Validation & PQ aspects of the project. Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort. Act as SME on the process & equipment within the assigned area. Providing technical and validation oversight to process, design and project delivery teams and coaching to associate personnel within the assigned area. Implementing the requirements as outlined in the site & project Validation Master Plan(s). Coordination of engineering sub-teams in the assigned area during execution of Cycle Development & Validation activities. Authoring and reviewing standard operating procedures and technical reports including PQ protocols. Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross-functional groups and/or validation counterparts. Supporting regulatory submissions as required. Owning Change Management process for Equipment introduction within the assigned area for qualification/validation up to PQ stage. Effective application of Lean Six Sigma and Change Management tools in the Validation group by: Leading by example in achieving results by using industry standard tools and processes Facilitating problem solving & risk assessment (FMEA) projects/meeting. Making problems visible and striving for continuous improvement. Serving as a key member during internal audits and external inspections/audits. Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners. Leading and supporting various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc). Representing the site as required in internal collaborations through Manufacturing Division Communities of Practice (CoP) for Validation and C&Q to include sharing of best practices in C&Q/Validation and investigation activities. Keeping up to date with scientific and technical developments, best practices and attending seminars as required. Maintaining continuous focus on quality and safety compliance and unflinching focus on the customer. Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed. Experience, Knowledge & Skills: This role requires an experienced individual with a minimum of 6 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices. A self-starter and results-focused, the successful candidate will have strong contemporary knowledge, and the ability to work independently and on multidisciplinary teams. The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours. S/he will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment. With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence. The candidate will also show ambition and drive to develop and advance within the role. Preferred Experience and Skills: Minimum 6 years C&Q/QA/QC/Validation experience in highly regulated industry. Minimum 2 years process equipment C&Q/QA/Validation experience on Greenfield/Brownfield, Large Scale Project or new facility introduction. Presenting of QA/QC/Validation documents to regulatory agencies/inspectors and defending approach. SME on Equipment Qualification on any; Cleaning & Parts Washers for in-process components / Vaporised Hydrogen Peroxide Isolators/ Clean Utilities & Transfer Panels / Vial & Syringe Filling & Inspection. Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines. Experience with liaising with other departments – Engineering, Automation, Technical, Operations, EHS and QA. Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection. Desirable but not essential; Vial & Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI. Clean Utilities and HVAC system Qualification. New facility brown/green field facility introduction experience, or training & developing a team within a commercial manufacturing environment. Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies. Experience with sterile processing and sterilisation technologies is advantageous. Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus. Project Management experience/training in use of Project Management tools and software tools. Use of Delta V and associated new Phase development and Qualification works. Qualification: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences, Computer Sciences or applied Technical / Engineering qualification. The successful candidate will also have a proven track record in delivering excellence. #J-18808-Ljbffr

Tipperary, Ireland | Posted on 04/11/2025 Industry: Pharma/Biotech/Clinical Research Work Experience: 4-5 years 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, and mentorship through 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 met. Overview: The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities at the facility. Requirements Key Result Areas and Primary Activities: Review and approve production and analytical documentation accompanying the release of drug substance, drug product, and packaged finished goods to ensure conformance to appropriate SOPs, GMP, and regulatory requirements, including supporting QP certification. Perform and review complaints and deviation investigations, change controls, and CAPAs. Create and maintain assigned SOPs. Compile data for reports and presentations, provide data interpretation, and draw conclusions. Complete audits to ensure compliance with SOPs, GMPs, and applicable regulations. Support product recalls and stock recoveries as appropriate. Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilize this network to help resolve comments and issues that arise during audit and review. Identify compliance gaps and make recommendations for continuous improvement. Assist in the induction process for new starters and training of other staff. Generally, follow standard procedures and consult with manager/supervisor on exceptions. Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements. Keep abreast of cGMP requirements as described in applicable worldwide regulations. Represent the department on cross-functional teams. Additional activities as assigned by the manager/supervisor. Skills and Education Required: The Specialist is required to possess a degree in a Science or Engineering discipline plus some industrial experience. Alternatively, they must possess considerable industrial experience. #J-18808-Ljbffr

Tipperary, Ireland | Posted on 01/06/2025 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 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 Quality Specialist – Quality Systems supports the Quality Systems activities in both the Drug Substance and Drug Product. The Quality Specialist participates as a member of the Quality Systems Team. Requirements Role Functions: The incumbent ensures timely and effective completion of the Quality Systems core functions in accordance with schedules and policies, procedures, and guidelines. Complete sub-system ownership responsibilities as per the site System Ownership list. Quality SME for Process, Cleaning, Water, Equipment: Provide leadership, through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility. Participate in and support the site PVC (Process Validation Committee), WVC (Water Validation Committee), CVG (Cleaning Validation Group), and Equipment Qualification Validation Committee (EQVC). Approve all validation documentation and ensure compliance with policies, procedures, and guidelines. Ensure that validation status is maintained following changes/modifications. Support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams. Develop Validation Summary Reports and assist in developing overall Quality plans for major projects. Work with other areas in the industry to predict future trends in validation and determine best practices. SAP Quality Process Steward. Quality SME for Change Control: Principal Quality contact for all site change requests (with impact on processing) – Provide Quality and change analyst review for all change requests through all stages of the change control process ensuring compliance with site policies, procedures, and guidelines. Principal Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes. Laboratory QA oversight. Support and approve the systems supporting laboratory functions, instrumentation, and GLIMS. Provide Quality oversight and approval for laboratory incidents/investigations and documentation. Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate). Microbiology Point of Contact: Knowledge of microbial requirements in the pharmaceutical industry, to liaise with site Microbiologist for all microbial issues (e.g., water, utilities, environment, excipient, or product) as necessary. Quality Agreement System Management: Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships. Interact and communicate with SD&PM, relevant stakeholders, and external parties to ensure appropriate Quality Agreements are current, approved, on file, and retrievable. Annual Review System Management: Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems including automation are completed to meet the Annual Review schedule. Creation, review, and approval of Site Quality documentation including: Site Master File, Validation Master Plan, policies, or procedures. Quality Oversight of site application User Access Reviews. Approval of all designated user access reviews, ensuring compliance with site policies and procedures. Quality Council: Manage the annual quality council schedule. Manage the monthly quality council agenda, minutes, and action follow-up. Supplier Change Evaluations - Quality Role: Review and approve Supplier Change Evaluation documentation. Generate quality/technical agreements with suppliers as appropriate. Supplier and Customer complaints: Participate in the investigation and review of any internal/external customer complaints in accordance with agreed lead-times. Participate in the investigation and review of any supplier complaints in accordance with agreed lead-times. Filing & Licence maintenance and Regulatory Requests follow-ups: Review and ongoing maintenance of site licences. Provide site documentation to support product filings in accordance with CMC requests. QA Regulatory Data: Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings. Assure the accuracy and integrity of all data and information through a timely review program. Returned Goods: Manage the segregation and disposition of all returned goods. Support the internal GMP walk-down and scheduled audits program. Support hosting of site Regulatory Inspections. Special Features: The incumbent operates as part of a self-directed team in carrying out day-to-day functions and assigning priorities. The incumbent monitors appropriate performance metrics to ensure that the CoE delivers on all responsibilities in line with business needs. On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems and participates in cross-functional interdepartmental teams. The incumbent must be assertive with excellent communication skills, who can develop cross-functional relationships and network outside the plant. The incumbent promotes GMP awareness at the site. Validation principles and guidelines. Understands key business drivers and uses this knowledge to make decisions and prioritize. System Development Life Cycle. Business: The Specialist must demonstrate the core values and behaviours. The Specialist must possess a high standard of knowledge and skills in the following areas: Computer Applications: Word, Excel, Access, eLogs, File, and Email Management. Meetings Management. Technical report writing. Time management. Analytical Problem-solving skills applied to issue identification and resolution. Responds to non-standard requests. Supports cross-functional investigations. Timely decision making. Inclusion behaviours. Leadership: Strong Communication skills both written and oral including persuading others. Pro-active approach. Planning and scheduling. Brainstorming/Ideas generation - tools and techniques. Interpersonal Skills. Interpersonal Team membership and leading Skills (e.g., Listening, integrating diverse perspectives, adds value to the achievement of team goals). Qualifications: Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field. #J-18808-Ljbffr

Dunboyne, Ireland | Posted on 04/01/2025 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, 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 QA Operations role will lead Quality Assurance activities at the Research & Development Division. The role is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. The role will be responsible for maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations. The Quality Assurance Operations will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. The Quality Assurance Operations will provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines/Policies and regulatory requirements, as required. Hybrid Role: Hybrid working must be on site a minimum of 3 days/week. Requirements Responsibilities: Lead, facilitate, and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance with GMP and site requirements at the facility. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals, and commercial/clinical operations at the facility. Complete QA operational duties related to product disposition including incoming material release and the performance of detailed review of eBR prior to QP release. Evaluate new and prospective regulatory guidance and industry best practices and determine the impact on Quality systems, identifying and implementing appropriate updates where required. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required. Assist in the creation and maintenance of QA policies, SOPs, and reports in line with site requirements. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Participate in and support risk management activities in line with relevant guidance and best industry practice. Assist in the execution of the internal audit program including the performance of audits as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Ensure the escalation of compliance risks to management in a timely manner. Educational and Experience Requirements: 8-10 years’ experience, ideally in Quality Assurance, Quality Control, or Technical Operations within the Biological and/or pharmaceutical industry. Project Manager capability with significant understanding of Operations. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME. Strong written and verbal communication skills. 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. Strong attention to detail and precision in preparing and reviewing GMP documentation. Experience in quality management systems such as Veeva, SAP, PAS-X, etc. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA, and other authorities related to Biologics and/or Pharmaceuticals. Experience in direct interactions with regulatory agencies during site inspections. #J-18808-Ljbffr

Sample Management Technician-QC Bioanalytical Laboratory 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. ‘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 regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: A vacancy for a Lab Technician within the QC Bioanalytical laboratory has opened up. This is a great opportunity for recent science graduates and those looking to get experience within a GMP laboratory setting. Requirements Role Functions: Sample Management within the QC Bioanalytical Laboratory. This will include management of the samples from receipt through to disposal. Aliquotting of in-process, release and stability samples. Daily calibration of instruments within the QC Bioanalytical Laboratory e.g. balances, pH meters etc. Maintenance and clean down of equipment within the QC Bioanalytical Laboratory e.g. HPLCs, plate washers, PCRs, and BSCs. General lab housekeeping. This will include waste management, reagent stock checks, and maintenance of glassware within the laboratory to support testing. Solution preparation required for testing e.g. HPLC mobile phases, raw materials solutions etc. Support MPS activities within the QC Bioanalytical Laboratory. Perform periodic reviews of lab systems as required. Experience, Knowledge & Skills: Experience preferred but not essential. Relevant experience and skill sets in their area of expertise that add value to the business; ideally in a manufacturing, preferably in a GMP setting. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA tests. Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices. Knowledge of cGMP & Laboratory Quality Systems. Effective communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner. Qualifications & Education: Degree qualification in Science/Chemical Engineering/Biological Engineering. #J-18808-Ljbffr

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 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. 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 with regards to quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met. Overview: MS&T Bioprocess lead supports the development of the site, providing leadership and Drug Substance technical support, in the Process Sciences Laboratory. Leads/participates in cross-functional teams to deliver all project and investigational activities on schedule. The successful candidate will develop a talented team of Manufacturing Science & Technology Scientists in the delivery of new products for commercial operations. Hybrid model potentially 2 days remote working. Requirements Responsibilities: Reporting to the Manufacturing Science & Technology Laboratory Lead, the responsibilities include, but are not limited to the following: Manage, coach, and mentor the MS&T drug substance team in performing advanced technical experiments. Inspire, reward, and develop individuals, helping them to reach their potential. Technical Lead for MS&T Process Sciences and the site. Provide proactive, technical oversight of the biologics inline & pipeline products. Lead technical assessments for process investigations, risk assessments, evaluation of specifications, and material qualification. Coach the team on development and execution of technical studies, continuous improvement of existing biologics processes, and for new product launch. Complete experimental design, execution, data analysis, and interpretation for improvement programs. Oversight of the product robustness trends observed in commercial operations and alignment with laboratory models, such as SIMCA for multivariate data analyses. Lead and/or support deployment and use of various digital tools at the facility: Leverage these tools to deliver business value through predictive/proactive issue resolution, rapid investigation closure, and improved yield/throughput. Assist in the regulatory authoring and review of technical documentation, technical report writing, and global regulatory submissions. Support the creation of the laboratory budget and review actual performance against forecast. Skills & Education Required: Ideally a Master’s in Biological Sciences/ Chemical Engineering/ Biological Engineering/Chemistry. 8+ years directly related working knowledge in academia, pharmaceutical or biotechnology company – along with a working familiarity of current regulatory requirements and current Good Manufacturing Practices. The successful candidate will also have demonstrated the ability to deliver projects and programs, with a strong understanding of lean and laboratory operations. 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. #J-18808-Ljbffr

Tipperary, Ireland | Posted on 03/25/2025 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 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. Overview A fantastic opportunity has arisen for a Maintenance/Reliability Engineer. This position will play a key role within the site engineering team ensuring Maintenance Systems are installed and managed to meet best practice and all compliance requirements. Requirements Responsibilities Work with capital projects to coordinate the implementation of Maintenance Systems (equipment registrations, preventive maintenance & calibration routines, Condition Monitoring, spares on the site CMMS & engineering handover documentation) for new facilities & installations at the Site. Develop and manage regulatory inspection programmes (e.g. Pressure, Lifting & F-Gas Systems). Develop and update Site SOPs as required. Skills & Qualification Required: A 3rd level qualification in a technical discipline or demonstrated equivalent maintenance/facilities experience. Knowledge and experience of CMMS systems (SAP & Procal) is essential and the implementation of systems. Minimum 2 years’ experience in a maintenance/facilities environment, preferably in a Manufacturing GMP environment. Good understanding of World Class Maintenance & Calibration practices and expectations including condition monitoring strategies and technologies. Knowledge of maintenance systems and work practices for both electrical/instrumentation and mechanical crafts. Good technical writing skills for PM and Calibration Routine development. Knowledge of Irish, European, and International Codes, Standards, and Practices. Analytical mindset, data-driven with attention to detail on systems. #J-18808-Ljbffr

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