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 of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: This Technical Engineering role will play a key part in the development of client site drug product facility. This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration. The Technical Engineering role will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable standards for Quality and EHS compliance. Responsibilities: Safety: Work collaboratively to drive a safe and compliant culture. Collaborate with multiple partners (e.g., network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering at Global Technical Forums as required. Compliance: Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlight any issues around compliance. Process Engineering & Validation: To lead and execute process engineering and validation activities to support the technical transfers. Projects: To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects, and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross-functional teams to establish scope in improvement projects as we ramp up to a fully commercial site. Continuous Improvement: To manage and deliver on all technical/Validation/Quality Notification/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting. Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g., Structured Root Cause Analysis, Statistical Process Control, Data-driven decision making). Drive collaboration between group functions and proactively look for synergies and innovative ways of doing work. Constantly assess our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant. Technical Expertise: Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation. Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects. May be required to perform other duties as assigned. Qualifications, Skills and Education Required: General: Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage. Proven track record in delivering results in a world-class supply organization. A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment. Innovative thinker, with excellent decision-making and problem-solving skills. Experience of working in a cross-functional environment. Knowledge of and experience in applying Six Sigma and Lean methodologies. Positive, flexible action-oriented attitude. Technical: Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. In-depth knowledge and experience of Sterile filling processes and equipment, especially aseptic processing. Experience of executing and/or managing through equipment and process validation in a sterile environment. Good shipping/Filter/Cleaning validation knowledge required. Knowledge of QbD/CPV desirable. Excellent report, standards, policy writing skills required. Automation and MES knowledge. Proficiency in Microsoft Office and job-related computer applications required. Lean Six Sigma Methodology experience desired. Experience in audit preparation and execution desired. Having a strong safety ethos. Strong Data Analysis capability. Have a proven record of process improvement implementation. Proven record in planning and basic project management of a team to deliver on time/schedule and cost. People: The passion to expand the future. Ability to participate in highly effective teams. The desire to continuously learn, improve and develop. A great communicator, decisive decision-maker with a proven ability to deliver excellence. Strong leadership and interpersonal skills. Willingness to support the team and a strong focus on delivering excellence. High personal integrity, credibility, energy, and flexibility. Strive to be innovative in how we do business. Engage with our business colleagues and learn from them as well as from our own experiences. Vendor liaison: Self-motivated and flexible approach. Effective time management and multi-tasking skills. Excellent attention to detail. Goal/results oriented. Demonstrable analytical and systematic problem-solving skills. Training skills. Strong change management skills. Effective conflict resolution skills. Education: Degree qualification or equivalent (Science, Engineering, Technical). Green Belt preferable. Reporting to: Technical Engineering Lead #J-18808-Ljbffr
Dunboyne, Ireland | Posted on 12/06/2024 Industry: Pharma/Biotech/Clinical Research Work Experience: 1-3 years City: Dunboyne State/Province: Meath Country: Ireland Job Description About PSC Biotech Who are we? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top Pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our 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. An amazing opportunity has arisen for a QC Analyst in Analytical Testing in our new state-of-the-art single-use multiproduct Biotech facility. In our start-up site, the role will be responsible for Quality Control testing and all associated laboratory activities related to Biochemistry and Analytical Methods. What you will do: Bring energy, knowledge, innovation, and influence to carry out the following: Perform a variety of routine analytical techniques and associated documentation, including but not limited to Capillary Electrophoresis, UPLC, HPLC, GC, and Wet Chemistry methods in compliance with GMP requirements. Support activities including general lab readiness, audit readiness, laboratory equipment qualification, and analytical method technical transfer, verification, and validation. Drive the development of technical skills through coaching and motivate a high-performing culture across the team. Foster a continuous improvement environment and bring strong problem-solving and troubleshooting capabilities. Consistently deliver on specific area Key Performance Indicators. Operate to the highest standards of Safety, Quality, and Compliance. Demonstrate a commitment to learning and personal development that supports Quality, EHS, L&D, and continuous improvement. Requirements What skills you will need: In order to excel in this role, you will more than likely have: 1-3 years’ experience in the biotechnology and/or pharmaceutical industry, particularly in relation to Capillary Electrophoresis, UPLC, HPLC, or GC testing. Preferably Lean Six Sigma experience. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on your own initiative in a constructive manner. Flexible and self-motivated. #J-18808-Ljbffr
Dublin 15, Ireland | Posted on 03/07/2025 Responsibilities Participate in all phases of the software development lifecycle, including discovery, analysis, requirements definition, solution design, code development, testing, deployment and support. Work closely with team members to develop maintainable, performance-optimized solutions. Work directly with developers, quality assurance, and product management to report, track, and resolve critical issues. Collaborate cross-functionally with technical/non-technical stakeholders to gather and understand the requirements. Troubleshoot issues experienced by customers and internal staff. Participate in all aspects of testing, including unit, functional, regression, load and system testing. Demonstrated analysis, problem solving and troubleshooting. Design solutions around SQL and NoSQL database architectures. Evaluate new tools and technology to ensure an automated and stable environment. Work independently and meet deadlines in a fast-paced, Agile environment. Provide system administration efforts for systems in a cloud-based highly-available and highly-scalable environment. Additional responsibilities as required. Requirements Requirements Bachelor’s degree in Computer Science, Engineering, or a related field. Portfolio of projects to review is a plus. 4-8 years of software development experience or related experience. 4+ years of experience in PHP development with Object-Oriented development. Experience with SQL and NoSQL database systems. Experience with both Windows and Linux servers. Experience with web application servers like Apache, NGINX, IIS, etc. Experience in the following is a plus: #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, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: This Technical Engineering role will play a key part in the development of client site drug product facility. This role is to lead activities to deliver on the Tech Transfer requirements needed to support New Product Introduction. This includes but is not limited to: Tech Transfer, Validation programs & strategies, Technical support and process improvement projects, network support & collaboration. The Technical Engineering role will collaborate across functions, supporting, coaching and facilitating project sub-teams. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable standards for Quality and EHS compliance. Requirements Responsibilities: Safety: Work collaboratively to drive a safe and compliant culture. Collaborate with multiple partners (e.g., network groups, third parties, vendors, quality, donor sites, Supply chain, IPT) in achieving excellence in technical transfer programmes. Serve as technical engineering representative for internal technical group discussions and represent Technical Engineering at Global Technical Forums as required. Compliance: Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Required to be compliant via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance. Process Engineering & Validation: To lead and execute process engineering and validation activities to support the technical transfers. Projects: To lead and manage multiple Technical Engineering projects needed to support the business. This includes but is not limited to: Process improvements, capital projects, and Lean projects across multi-disciplined functions which may also require global and network support and collaboration. Responsibility to lead an integrated project team in delivering the project business case and collaborating closely with cross-functional teams to establish scope in improvement projects as we ramp up to a fully commercial site. To manage and deliver on all technical/Validation/Quality Notification/Change control/Project support within the technical engineering team. Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting. Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g., Structured Root Cause Analysis, Statistical Process Control, Data driven decision making). Drive collaboration between group functions and proactively looking for synergies and innovative ways of doing work. Constantly assessing our systems and processes to see what improvement we can make to work smarter and more efficiently while all the time being compliant. Technical Expertise: Act as a subject matter expert on (1) Equipment Design (2) Assisting in C&Q execution and planning; (3) Process design and validation. Act as a liaison with both global engineering services and facilities as well as specialist vendors on process requirements to deliver projects. May be required to perform other duties as assigned. Qualifications, Skills and Education Required: General: Considerable experience in a comparable role; would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers/scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage. Proven track record in delivering results in a world-class supply organisation. A strong career history in pharma (ideally aseptic filling) and familiarity with a highly regulated environment. Innovative thinker, with excellent decision-making and problem-solving skills. Experience of working in a cross-functional environment. Knowledge of and experience in applying Six Sigma and Lean methodologies. Positive, flexible action-oriented attitude. Technical: Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. In-depth knowledge and experience of Sterile filling processes and equipment especially aseptic processing. Experience of executing and/or managing through equipment and process validation in a sterile environment. Knowledge of QbD/CPV desirable. Excellent report, standards, policy writing skills required. Automation and MES knowledge. Proficiency in Microsoft Office and job-related computer applications required. Experience in audit preparation and execution desired. Having a strong safety ethos. Strong Data Analysis capability. Have proven record of process improvement implementation. Proven record in planning and basic project management of a team to deliver on time/schedule and cost. People: The passion to expand the future. Ability to participate in highly-effective teams. The desire to continuously learn, improve and develop. A great communicator, decisive decision-maker with a proven ability to deliver excellence. Strong leadership and interpersonal skills. Willingness to support the team and a strong focus on delivering excellence. High personal integrity, credibility, energy and flexibility. Strive to be innovative in how we do business. Engage with our business colleagues and learn from them as well as from our own experiences. Self-motivated and Flexible approach. Effective time management and multi-tasking skills. Excellent attention to detail. Goal/results orientated. Demonstrable analytical and systematic problem-solving skills. Education: Degree qualification or equivalent (Science, Engineering, Technical). Green Belt preferable. Reporting to: Technical Engineering Lead #J-18808-Ljbffr
Tipperary, Ireland | Posted on 03/07/2025 Industry: Pharma/Biotech/Clinical Research Work Experience: 5+ years Country: Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, and mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations with regards to the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: An exceptional opportunity for an experienced S&E Specialist ideally with specialization in Process Safety to join the Environmental Health & Safety team at an upper-tier COMAH site. You will provide technical guidance to the site as well as ongoing projects to ensure compliance with all relevant legal requirements related to Process Safety, our company's corporate standards, policies, procedures, guidelines, and industry best practices. 100% onsite role. Requirements Required Experience and Skills: 5+ years of EHS, Engineering, or Operational experience in chemical, pharmaceutical, biochemical, petrochemical, or process-related industry Knowledge of HAZOP, LOPA, ATEX, and Change Control Drive to engage others and have excellent interpersonal, communication, and leadership skills Ability to maintain focus on key goals and priorities, but also analyze the detail to facilitate problem resolution and ensure project success Knowledge and experience working with EHS regulations Strong written and verbal communication skills Ability to influence both horizontally and vertically Responsibilities: Participate in project design reviews, HAZIDS, Risk Assessments, and HAZOPS for proposed new equipment, modifications, and new product introductions Ensure management of change processes are followed and serve as EHS reviewer for planning of activities impacting facility operation Co-ordinate support from relevant SMEs such as Industrial Hygiene, Process Safety, Environmental, Machinery Safety, etc. Provide Process Safety Support for Existing Processes, New material introductions, and Project Work As required, serve as a site EHS representative during risk assessments, mechanical completion, commissioning, and qualification activities, participate in project walk-downs and start-up activities for assigned systems Serve as a leader in demonstrating and implementing a strong EHS culture across the site Participation and EHS Reviewer in the site's Safety Relief Device sizing program as required (training will be provided as needed). Monitor developments and advise Management on changes in Process Safety/COMAH related Standards and Legislation The successful candidate will be able to demonstrate a proven track record to influence others, have strong knowledge of safety programs, and be a convincing communicator with strong interpersonal skills. The ideal candidate is a self-directed, technically strong individual who can work in a multi-functional team environment. Education: Bachelor’s degree in Chemical Engineering or Engineering or related Safety or Environmental field of study #J-18808-Ljbffr
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 include the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Overview: We are seeking a highly skilled and motivated Product Manager to lead the design and creation of a new customer portal for our company. The portal will enable authorized users to access support, purchase additional products, and view new analysis of their data amongst other functionalities. The Product Manager will be responsible for overseeing the entire product development lifecycle, ensuring seamless integration with Salesforce, Okta, and our install base management system. This is a 6-month contract position with the potential for extension based on project needs and performance. Requirements Role Functions: Project Leadership and Management: Lead the project from inception to completion within the 6-month timeframe. Define and communicate the product vision, strategy, and roadmap. Collaborate with cross-functional teams including engineering, design, marketing, sales, and customer support. Stakeholder Management: Engage with stakeholders to gather requirements, define project scope, and establish clear deliverables. Conduct regular status updates and maintain transparent communication with all stakeholders. Design and Development: Work with UX/UI designers to create intuitive and user-friendly interfaces. Ensure the portal design aligns with brand guidelines and customer expectations. Oversee the development process, ensuring timely progress and addressing any technical challenges. Integration and Testing: Coordinate integration efforts with Salesforce, Okta, and the install base management system. Develop and execute a comprehensive testing plan to ensure flawless functionality. Manage user acceptance testing (UAT) with a focus on gathering feedback and iterating on the product. Data Analysis and Reporting: Incorporate appropriate instrumentation to understand usage and effectiveness of the product. Monitor and analyse user engagement metrics to inform continuous improvement. Experience, Knowledge & Skills: Experience: Proven experience (5+ years) in product management, preferably with a focus on customer portals or SaaS products. Demonstrated success in leading cross-functional projects from concept to launch. Experience integrating third-party systems (e.g., Salesforce, Okta). Experience working in large, complex corporate environments. Knowledge: Strong understanding of product development lifecycle and agile methodologies. Familiarity with UX/UI best practices and design principles. Knowledge of data analytics and reporting tools. Skills: Excellent project management skills, including the ability to plan, organize, and prioritize effectively. Strong analytical and problem-solving skills. Effective communication and stakeholder management abilities. Ability to work under pressure and meet tight deadlines. Technical proficiency to understand integration requirements and coordinate with engineering teams. Qualifications & Education: Proven experience more important than qualifications or education. #J-18808-Ljbffr
Industry Pharma/Biotech/Clinical Research Work Experience 1-3 years City Carlow State/Province Carlow Country Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting. Job Description: Reporting into the Maintenance Lead, the Mechanical Technician will be responsible for maintaining and troubleshooting process devices, instrumentation, and controls in support of vaccine manufacturing. You will ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety, and reliable supply to our customers. 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) Required to operate and clean the process equipment as necessary. Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtime. Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc. Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles. Operate, troubleshoot, and repair complex systems which may include Autoclaves, Glassware Washers, Single-use mixers, HVAC, Isolators, filling line and inspection lines under minimal supervision in a highly regulated, cGMP environment. Interpret P&ID’s, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system. Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary. Assist in general facility upkeep and provide responsive customer support with emphasis on customer satisfaction. Participate effectively in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same. Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. What skills you will need: Time serviced MAMF Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required. Prior experience in a good manufacturing Practices (cGMP) and regulated pharmaceutical production environment is essential. Extensive hands-on experience of preventive/reactive maintenance. Understanding of mechanical/electrical/Instrumentation/pneumatic processes. Proficiency in Microsoft Office and job-related computer applications required, with excellent communication skills on technical subjects. #J-18808-Ljbffr
Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. Role Description: Process Engineer - Tech Transfer / NPI Hybrid – Day’s role with expectation to support shift intermittently when Floor activities/studies are ongoing. New exciting opportunity now exists on our Client Site for a Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager. Our new team member will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross-functional or single function teams including liaising with vendors or above site groups. You will typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will consider applicants from other working environments as long as they have technology transfer experience. Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable but not a necessity for this role. Our Engineers support internal and external manufacturing operations remain operational, continuously improve, and innovate. Requirements Role Functions: Design/Author/Review/Approve/Execute qualification/validation documentation and process development studies in line with the standard approval process. Design/Author/Review/Approve/Execute development of change controls. Contribution to Kaizen events as appropriate. Technical input into quality notification by authoring/reviewing/approving investigations. Execution of equipment/qualification validation programs; including re-qualification and re-validation. Support continuous improvement through Lean Six Sigma methodologies. Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues. Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP). Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills: Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline. Min 3 years’ experience ideally in manufacturing, preferably GMP Setting. Demonstrable experience of leading technical related projects. Evidence of continuous professional development is desirable. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Proficiency in Microsoft Office and job-related computer applications required. Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner. #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 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 with 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 met. Job Description The Project/Equipment Engineer reports to the Senior Manager for Engineering Projects and is responsible for scoping and executing technical projects supporting Drug Product manufacturing within Formulation, Component Preparation, Vial/Syringe Filling, and Lyophilisation. This includes qualification of new equipment and implementation of associated reliability and maintenance programs. Requirements Key Responsibilities Project management and execution of assigned projects including project prioritization, resource management, status management, and external communication. Working with various stakeholders to scope projects and ensure requirements are satisfied. Project input will span from concept through design, construction, commissioning, and operation. Coordinating the introduction of new processes, equipment, and materials including problem solving and troubleshooting equipment issues prior to qualification & start-up. Development and implementation of maintenance programs and spare parts inventory optimization with the introduction of new equipment. Ability to translate strategic/emerging technology solutions into pragmatic executable plans. Development and management of change controls. Participate as a member of multidisciplinary site and multisite teams. Development of detailed specifications, engineering documents, protocols, and standard operating procedures. Work in a collaborative manner within the Process Teams structure and contribute to Root Cause Investigations and Cross-Functional Investigations. Work collaboratively with the System Owners, Maintenance Supervisors & Technicians, Capital Project Engineers, and Vendors to perform equipment upgrades and/or retrofits. Perform all tasks with due care and attention ensuring compliance with Good Manufacturing Practices and company requirements, policies, and procedures. Support a safe working environment by complying with environmental health/safety practices, rules, and regulations. Travel may be required to support the execution of projects. Experience and Qualification: Bachelor’s degree in engineering (Mechanical, Electrical, or Chemical) or relevant experience. Typically, 3+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment or Automated Inspection and/or Automated Device Assembly, Labelling, and Ancillary processes. Strong mechanical capability with hands-on experience in a technical role within a high-volume manufacturing environment is advantageous. Demonstrated experience in a GDP Compliant environment. Experience in MS Office, MS Project, Change Control & Document Management Systems. Proven ability to work cross-functionally, delivering technical solutions and implementing improvements. Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results. Technical report writing and communication/presentation skills. Ability to work to tight deadlines in a fast-moving environment. #J-18808-Ljbffr
Job Description About PSC Biotech Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients. ‘Take your Career to a new Level’ PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/Biotech Industry. We offer a permanent contract of employment giving exposure to working in top pharmaceutical client sites in a diverse cultural work setting. Employee Value Proposition Employees are the “heartbeat” of PSC Biotech; we provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met. Role Description: As part of the IPT team, perform various production and operations-related tasks as part of an empowered team to aid in the manufacture and reliable supply of product. Ensure that objectives are effectively achieved, consistent with client’s requirements to ensure compliance, safety, and reliable supply to our customers. Requirements Role Functions: Operate and/or monitor production activities and support equipment, using MES/DCS and PLC-based systems, to ensure optimum equipment uptime and target outputs. Equipment will include, yet is not limited to, parts washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro Tunnel, Debagger, and filling machines. Clean room cleaning, housekeeping, and materials management in all production areas while focusing on continuous process improvement using Lean Principles. Manage equipment flow, including tracking soiled and clean hold times, proper labeling, and inventory management of clean and sterile equipment using Kanbans and automated MES system to set QC status and expiry of sterile equipment. Maintain process equipment, completing preventative maintenance and equipment troubleshooting and repairs where qualified to perform tasks. Participate effectively in writing/revising/rolling out accurate operational procedures, training materials for various IPT systems; ensure all work is carried out in line with the same. Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate. Perform root cause analysis, using standard tools and methods, to resolve system issues e.g., FMEA, Fishbone diagrams, 5 why’s, etc.; implement subsequent corrective action through the change management system. Required to comply with client Global Policies, Procedures, and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Experience, Knowledge & Skills: Core Competencies: Technical: Sterile filling processes and equipment. Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices. Proficiency in Microsoft Office and job-related computer applications required. Business: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers. Understand the specific responsibilities of all departments as they relate to one's own department, understanding the business processes one’s department supports. Self-motivated. Flexible approach. Effective time management and multi-tasking skills. Excellent attention to detail. Goal/results-oriented. Leadership: Focus on Customers and Patients. Act with Candor and Courage. Make Rapid, Disciplined Decisions. Drive Results. Build Talent. Demonstrate Ethics and Integrity. Qualifications & Education: Typical Minimum Education: Leaving Certificate or equivalent required. Apprenticeship, Certificate, or Diploma preferred, ideally in a related discipline. Typical Minimum Experience for this Grade/Level: Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. #J-18808-Ljbffr
