PSC Biotech® Corporation is seeking an Engineering Specialist (Validation) for its Carlow site in Ireland. The role involves designing and executing validation documentation, resolving technical issues, and engaging with multiple departments to ensure compliance with regulatory standards. Ideal candidates will have relevant qualifications in pharmaceutical or engineering fields, experience in GMP environments, and strong communication skills. Familiarity with systems like DeltaV and Pi System is advantageous. A focus on continuous professional development is expected. #J-18808-Ljbffr
PSC Biotech® Corporation in Carlow, Ireland is seeking a QC Micro Technician to join their dynamic Microbiology laboratory. The role requires a Bachelor's degree in a related Science discipline and 1-2 years of experience in a GMP laboratory environment. Key responsibilities include ensuring data integrity, performing laboratory testing, and adhering to GMP and safety guidelines. This position offers an exciting opportunity to contribute to innovative health solutions in a compliant laboratory environment. #J-18808-Ljbffr
PSC Biotech® Corporation in Munster, Ireland, is seeking a laboratory professional to perform and document scientific experiments. The role involves executing procedures independently in BCoE studies, with responsibilities including microbial cell culture, fermentation processes, and maintaining laboratory quality. A Bachelor’s degree in Science or Engineering and at least 1 year of experience in the pharmaceutical industry are required. The position emphasizes adherence to GxP regulations. #J-18808-Ljbffr
Role Summary We are looking for a BioProcess Associate to join our Drug Substance team at our state‑of‑the‑art, fully integrated vaccine facility in Ireland. As a Bioprocessing Associate, you will be a key member in our fast‑growing, dynamic startup working with cutting‑edge technology. Responsibilities Manufacturing processes include DS Downstream Processing (DSP) and Upstream Processing (USP) and Buffer / Media preparation Carry out all production operations in the assigned area as per the relevant SOPs and Manufacturing Batch Records Assist in maintaining a safety‑orientated, cGMP compliant work environment at all times Write, review and revise area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions Training and mentoring of colleagues in SOPs, process execution and equipment operation Support Manufacturing team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule adherence, Overall Equipment Effectiveness (OEE), and team training Assist with the investigation of and operations deviations through Quality System, engaging with all relevant personnel and functions as appropriate Lead and actively participate in shift handovers Liaise with Shift Lead regarding issues that may arise within the production area, including highlighting of operational challenges Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Gemba, Method 1) to optimize efficiency and drive the culture of Continuous Improvement (CI) Support HAZOP and risk assessments as per requirements Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested Conduct all activities that are in accordance with Company policies, SOPs and global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate Support the development, commissioning and qualification of new vaccine drug‑substance manufacturing equipment and subsequent transition to commercial manufacturing Qualifications and Skills Demonstrated experience in bioprocessing, upstream or downstream Knowledge and experience of relevant cGMP, safety, and environmental regulations within the biopharmaceutical industry High level of adaptability working in a fast‑paced environment and champion change Experience with recording information in real time using electronic or manual systems Experience in executing operations while following SOPs, Batch Records and Manufacturing Controls Systems Experience working in Grade C, D and CNC environment is an advantage Excellent interpersonal skills, positive influence, team orientation, attention to detail, documentation skills, problem identification and problem‑solving skills Ability to work independently, and as a member of a self‑managed shift team in a dynamic, fast‑paced environment that requires flexibility and initiative Shift Pattern This position will initially operate standard office hours Monday‑Friday but will transition to an extended 7‑day shift pattern with 12‑hour shifts, designed to provide 24/7 coverage using a 4‑week repeating cycle. Two teams rotate through this schedule. Schedule Example Week 1: Work Monday, Tuesday, Friday, Saturday, Sunday (12‑hour day shifts), Off Wednesday and Thursday Week 2: Work Wednesday and Thursday only, Off the other 5 days Week 3: Same as Week 1: Work Monday, Tuesday, Friday, Saturday, Sunday Week 4: Same as Week 2: Work Wednesday and Thursday only #J-18808-Ljbffr
Overview Perform & document scientific experiments in collaboration with cross‑functional stakeholders as part of the BCoE or Site strategy, and/or in support of commercial & clinical product portfolio. Responsibilities Executes defined procedures independently to support BCoE studies and investigation activities with lab scale upstream processes in the multi‑product lab. In addition to quick learning of core scientific techniques, principles and protocols, owns small project portions reliable execution and able to summarizes findings. Understanding the principles of aseptic operation and experience in working in biosafety cabinets. Experience in daily operations with microbial cell culture (E. coli), including cell thawing and cell banking, seed train expansion etc. Experience in fermentation process, including fermenter inoculation, daily monitoring, sampling and in‑process analysis utilizing standard bioprocess analytical equipment. Basic understanding of mammalian cell expansion and it’s difference in comparison to microbial operations. Experience in processing of inclusion bodies is desirable. Produces accurate, reproducible data entries and maintains laboratory quality through adherence to safety and SOPs and able to troubleshoot common problems with guidance. Expands technical toolkit by adapting and troubleshooting process steps or assays, applies appropriate methods and interprets basic data trends. Updates and refines SOP/BPD documentation. Assists in drafting concise technical summaries. Understanding of fed‑batch and perfusion bioprocesses is desirable. Experience in depth filtration and ultrafiltration is desirable. Understanding of downstream purification process is desirable. General Execute and complete projects independently. Generate and review data, makes data analysis. Maintain up‑to‑date documentation of laboratory work carried out including documentation storage and archiving in accordance with GLP. Support updates of lab instructions, BPDs, SOPs, templates. Support maintenance and calibration of lab equipment with accompanying documentation. Contribute to the evaluation of new equipment. Be a team player with excellent communication skills. Play an active role in maintaining and enhancing the safety of the workplace and the laboratories. Comply with applicable GxP regulations, SOPs, HSE, & other guidelines in the laboratory as applicable. May be required to work periodically out of normal business hours, including weekends. Key Performance Metrics Adherence to project plans & deliverables Adherence to applicable GxP and EHS requirements Technical reports executed on time and on quality Efficient technical exchange with Project leads Education Bachelor’s degree or higher in Science or Engineering Experience A minimum of 1 year experience in the pharmaceutical industry or equivalent strong laboratory experience. Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics. #J-18808-Ljbffr
PSC Biotech® Corporation is seeking a Senior Associate Scientist in Cork, Ireland. The role involves applying scientific expertise in small-scale protein purification techniques to support process development and improvement. Candidates must have a degree in Biochemistry, Biotechnology, or Process Engineering with relevant experience. Responsibilities include project accountability, troubleshooting, and maintaining high standards of laboratory practices. The position offers a contract for 12 months with a focus on innovation and collaboration within the laboratory environment. #J-18808-Ljbffr
PSC Biotech® Corporation is seeking a BioProcess Associate to join the Drug Substance team at their innovative vaccine facility in Ireland. This role involves participating in manufacturing processes, maintaining a cGMP compliant environment, and training colleagues in Standard Operating Procedures (SOPs). Ideal candidates should have experience in bioprocessing and be adaptable to a dynamic team setting. The job follows a transition to a flexible 7-day shift pattern and includes responsibilities for achieving manufacturing KPIs. #J-18808-Ljbffr
Position Engineering Specialist (Validation) – Carlow Site – PSC Biotech. Responsibilities Design, author, review, approve and execute qualification/validation documentation and cycle development studies in line with the standard approval process. Design, author, review, approve and execute change control development and execution. Resolve technical issues encountered during study execution. Engage with Production, Maintenance and Quality representatives during performance qualification activities. Provide technical input and author or review investigations for quality notifications. Perform root cause analysis of system failures using standard tools and methods. Support continuous improvement through Lean Six Sigma methodologies. Serve as validation representative for cross‑functional projects and represent the validation team at global technical forums. Ensure compliance with global policies, procedures and guidelines, regulatory requirements and cGMP in day‑to‑day activities. Maintain compliance through documentation, risk assessments, corrective action closures, audits and inspections. Support regulatory audits and submissions as required. Collaborate to promote a safe and compliant culture in Carlow. May be required to perform other duties as assigned. Qualifications Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification. Experience operating as an individual contributor in a GMP manufacturing setting. Knowledge of CTU equipment qualification and thermal mapping equipment. Experience with exception/deviation management and change control. Demonstrable experience leading technical projects. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence and data systems (Pi System) within a GMP environment. Evidence of continuous professional development. Familiarity with Irish, European and International codes, standards and practices. Analytical ability to interpret complex data and link to equipment performance and out‑of‑spec findings. Report, standards and policy writing skills. Experience with equipment and process validation. Knowledge of sterile fill‑finish processes and equipment. Proficiency in Microsoft Office and job‑related computer applications. Excellent communication, presentation and interpersonal skills. Additional Knowledge Vial and Syringe Processing Technologies. #J-18808-Ljbffr
Snr. Associate Scientist 12 month contract 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. Position Overview We are seeking a Senior Associate Scientist to apply scientific expertise on a variety of small-scale protein purification techniques to support process development, characterization, troubleshooting of manufacturing issues, and continuous process improvement. This role is a subject matter expert within the Technical Development and Services, Biological Centre of Excellence Laboratory and is open to candidates with downstream processing experience. Analytical experience or background would be considered. A thorough understanding of GMPs and ICH guidelines is an advantage. Responsibilities Accountable for designing and delivering assigned scientific projects & studies in line with overall BCoE business plan and technical agenda, with limited supervision. Accountable for the integrity of the data and scientific conclusions from assigned scientific projects. Support and lead root‑cause analysis investigations, troubleshoot processing problems and support more junior scientists with technical challenges and development of technical depth. Accountable for developing and maintaining small‑scale models and maintaining expertise in protein purification techniques and methodologies. Author protocols, work instructions, SOPs, risk assessments and technical reports to a high standard. Use scientific integrity and expertise to challenge the status quo and identify opportunities for improvement in lab practices. Accountable for developing & maintaining a high standard of Good Laboratory Practices (GLP). Responsible for developing cross‑functional project plans with other BCoE SMEs and stakeholders. Responsible for participating in the internal network of SMEs across the scientific and technical functions namely BCoE, Process Sciences and Analytical. Responsible for the communication and dissemination of scientific output to scientific & technical functions and BCoE stakeholders (e.g., presentations to internal functions). Responsible for designing discrete studies/experiments with appropriate supervision. Responsible for maintaining a culture of empowerment, accountability and continuous improvement within BCoE. Responsible for contributing to strong cross‑functional relationships through promotion of science and the work of BCoE across stakeholder groups, specifically Technical Operations functions. Responsible for maintaining a culture of Operational Excellence, namely Standard work and 5S. Responsible for adhering to BCoE procedures and practices specifically in relation to laboratory operations. Accountable for the health and safety of self and colleagues working together. Requirements PhD degree in a relevant scientific discipline (Biochemistry, Biotechnology, Process Engineering, etc.) with 0‑2 years’ experience of laboratory‑scale downstream techniques. Master’s degree in a relevant scientific discipline (Biochemistry, Biotechnology, Process Engineering, etc.) with 3+ years’ experience of laboratory‑scale downstream techniques. Bachelor’s degree in a relevant scientific discipline (Biochemistry, Biotechnology, Process Engineering, etc.) with 5+ years’ experience of laboratory‑scale downstream techniques. Commercial scale experience will also be considered. Some experience in analytical science will be an advantage. Working knowledge of pharmaceutical regulatory requirements appropriate to level and understanding of the cGMP manufacturing process for Biologics. Additional notes Laboratory work and manufacturing support activities will require the use or proximity of chemicals, laboratory and manufacturing equipment and instruments, and mechanical moving parts. Noise and vibration may be present. Periodic week‑end laboratory work and/or on‑call support will be required on a team rotation basis. #J-18808-Ljbffr
Job Overview Join our team in a dynamic Microbiology laboratory as a QC Micro Technician. We are looking for an enthusiastic and hard‑working individual with strong attention to detail, problem‑solving skills, and the ability to work independently or as part of a team. This is an exciting opportunity to contribute to our mission of delivering innovative health solutions. Responsibilities Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities. Perform laboratory testing to determine specification conformance and to support site targets, including but not limited to bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. Maintain an adequate, qualified, and compliant laboratory environment to conduct testing while adhering to appropriate PPE and safety requirements. Contribute to effective writing, revising, and rolling out of accurate operational procedures, training materials, and maintenance procedures for various quality‑related systems. Highlight any discrepancies, deviations, or non‑conformance in testing or work practices and support investigations as required. Ensure compliance with GMP and EHS guidelines at all times. Participate in training programs as required. Qualifications – Required Minimum of Bachelors Degree or higher in a related Science discipline 1-2 years’ experience in a GMP laboratory environment Good knowledge of GMP, GLP, and aseptic technique and Maldi experience Proficient computer skills and technical writing. Strong interpersonal and communication skills. Qualifications – Preferred Experience in a microbiology laboratory setting. Familiarity with bioburden testing, environmental sampling, WFI sampling, sample management, plate enumeration, and endotoxin testing. #J-18808-Ljbffr
