Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are now looking for a Maintenance Technician (Permanent role) to join our team in Dundalk, County Louth. This is a Day Shift role, covering Thursday to Saturday 12 hours shift (7am to 7pm). Summary Of Role Responsible for ensuring machine change over’s, stoppages and breakdowns are undertaken in a timely manner to targets and with minimum disruption to production schedules. Undertake planned routine maintenance and maintain schedules ensuring that all equipment and plant are able to operate safely, efficiently, and in compliance with GMP practices. Fault find to an expert level on Electrical and Mechanical systems. Multiskilled able to program PLC’s and to participate in technically involved projects to improve or create new processes. Mechanically able to design systems and develop to implementation. Implement continuous improvements on equipment and carry out to a high standard within GMP guidelines. Create MOC’s and manage through the QMS. Create design of experiments and use other fault-finding techniques to improve processes. Responsibilities Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department. Ensure that maintenance areas and equipment are kept in a clean, tidy and secure state (including storage areas). Adherence and recording of defined routine maintenance schedules; covering all equipment and plant. Rapid and flexible attention to all breakdowns/stoppages to minimise loss of production, liaising with Engineering Supervisor and Operational Engineering Manager. Carry out/Participate in A3 Problem solving activities on major issues and lead to Root cause. Analysis of equipment redesign of any systems/equipment to improve process. Planning and implementation of engineering improvement projects, designing and developing to Validation. Advise Engineering Supervisor and Operational Engineering Manager of any machine or plant which requires major repair or maintenance. Highlight potential areas for improvement within Production area regarding equipment or procedural changes. Liaise with Production on identifying areas for continuous improvement and implement changes using correct change procedure. Strip down, cleaning and reassembling of production equipment as per routine maintenance schedules. Perform machine set‑ups and changeovers to target times as required in line with production requirements. To actively assist in looking at ways to improve changeover times by procedure and method. Ensure the timely and accurate completion of all documentation and paperwork such as tooling logs, setting sheets, online working sheets, PPM sheets. Improve and maintain the levels of current Good Manufacturing Practice. Assist with the training of colleagues as required. The use of workshop equipment to manufacture piece parts and repair as required. Assist with projects on trials, and new product introductions as required. Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company. Essential Knowledge / Skills & Experience Bachelor’s or Associate Degree or Diploma / Certificate in Engineering. May substitute experience in lieu of educational requirements. 4 years’ experience. Proven track record of showing how results were delivered through management/leadership. Capability to follow set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets. Ability to manage multiple tasks. Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems. Self-motivated with a results driven approach. Flexibility to work across different shifts on request in line with business needs. Adaptable and ability to work collaboratively. Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.) Take care of your own health and safety and that of people who may be affected by what you do (or do not do). Co-operate with others on health and safety, and not interfere with, or misuse, anything provided for your health, safety, or welfare. Desirable Experience in a GMP or Regulated Environment. Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future. Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. We are looking for a QA Warehouse Specialist to join our team in Dundalk. Responsibilities Sample, approve, and release incoming goods, packaging materials, and products (where required) for use in production Request and review Certificates of Analysis (CoA) / Certificates of Conformance (CoC) for incoming goods, packaging materials, and products Review and file acetates for use during sampling activities Identify training needs and conduct staff training as required Maintain sampling documentation and archive retain samples Manage the Supplier/Customer Defect (SCD) system, including issuance of SCD numbers, coordination with customers and suppliers, and closure of SCDs Liaise with customers and suppliers on artwork-related queries and manage artwork approvals Review and approve Master Packaging Material Specifications Ensure high standards of housekeeping; conduct housekeeping audits and prepare reports Raise, investigate, and close deviations and Corrective and Preventive Actions (CAPA) as required Ensure all activities are conducted in compliance with current Good Manufacturing Practice (cGMP) requirements Assist in validation studies as required Ensure safe work practices are followed at all times, report safety issues immediately to the Safety Officer, and attend Health and Safety meetings Perform other duties as required from time to time in line with the overall goals of the company Qualifications Relevant experience may be considered in lieu of formal educational requirements Proven track record of delivering results Ability to work toward clearly defined goals, communicate progress effectively, and meet predefined targets Bachelor’s or Associate Degree, or Diploma/Certificate in Quality, Pharmaceutical Science, or a related discipline One to two years of experience working in Quality / QA Ability to manage multiple tasks and prioritize effectively based on business needs Strong problem-solving and troubleshooting skills, with a dynamic and proactive approach Self-motivated with a results-driven mindset Flexibility to work across different shifts as required in line with business needs Adaptable and able to work collaboratively within cross-functional teams Proficient in Microsoft Office applications (including Excel, PowerPoint, Word, etc.) Willingness to travel between sites based on company requirements Equal Employment Opportunity PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
PCI Pharma Services in Stamullen, Ireland, is seeking a Project Management Support role for new NPI projects. The ideal candidate will assist in project tracking, documentation, and communication across various teams. This position is suitable for recent graduates with a keen interest in project management and solid skills in Microsoft Office. Opportunities for learning and exposure to pharmaceutical processes are included. Join PCI in delivering life-changing therapies and be part of an inclusive workplace. #J-18808-Ljbffr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Key Responsibilities Support the setup and registration of new NPI projects, including updating trackers and documentation. Assist in compiling project timelines and tracking milestones. Attend internal and external project meetings and document actions, risks and decisions. Support maintenance of NPI dashboards and governance reports. Assist in preparation of customer presentation materials. Cross-Functional Coordination Liaise with operations, quality, supply chain, procurement and engineering teams to collect updates and support action tracking. Follow up on assigned tasks to ensure timely completion. Support communication of project updates across the business. Documentation & Compliance Support preparation and maintenance of project documentation in accordance with company SOPs. Assist in raising change requests where required. Develop an understanding of cGMP requirements and regulatory compliance standards. Ensure safe work practices are followed at all times and report any near misses to the Environmental Health & Safety (EHS) Department. Continuous Improvement Contribute to improvement initiatives within the NPI function. Assist in standardising templates, trackers and reporting tools. Participate in Lean or operational excellence initiatives where applicable. Learning & Development Complete structured training across NPI processes, governance, systems and tools. Gain exposure to customer interactions and on-site project reviews. Build understanding of commercial packaging and pharmaceutical manufacturing processes. Develop core project management skills including planning, communication and risk awareness. Undertake additional tasks or ad hoc projects as required to meet business needs within the scope of the role. Travel on company business as required (vendor, supplier or customer-based) Essential Knowledge / Skills & Experience Educated to EQF (European Qualifications Framework) Level 6 in a Technical, Engineering, Science, Pharmaceutical or Business-related discipline (recent graduate or graduating within current academic year). Strong interest in project management within a regulated manufacturing environment. Excellent written and verbal communication skills. Proficient utilisation of Microsoft Office applications (Excel, Word, PowerPoint). Strong organisational and time management skills. Analytical mindset with attention to detail. Ability to work collaboratively in a cross-functional team environment. Self-motivated with a proactive approach to learning. Desirable Internship, placement or work experience within pharmaceutical, biopharmaceutical, food or regulated manufacturing environment. Basic understanding of cGMP principles. Exposure to project management methodologies. Experience using project tracking tools (e.g. MS Project, Smartsheet). Skills & Aptitudes Strong interpersonal skills. Eagerness to learn and develop professionally. Ability to manage multiple tasks in a structured manner. Problem-solving capability with a logical approach. Customer-focused mindset. High level of integrity and professionalism aligned to PCI Values and Behaviours. Scope and Authority Supports NPI projects under supervision of Project Managers. No direct budget or people management responsibility. Responsible for adhering to company SOPs, Health & Safety and regulatory guidelines. Accountable for accurate tracking and reporting of assigned project activities. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
Main Purpose Of Job The primary purpose of the Data Analyst is to provide Data Analytics and Data Visualisation Solutions in support of the Full spectrum of PCI Data Analytics. The role requires drive and motivation with a natural curiosity to learn and the technical aptitude to transform complex data from PCI Data Lakes into actionable insights. The Data Analyst is the primary architect of the PCI reporting ecosystem, using Power BI for visualization and Smartsheet for workflow automation. Key Responsibilities Data Synthesis: Query and extract large datasets from JDE, Master Control, and cloud environments to identify trends and anomalies. Visualization & Reporting: Design, develop, and maintain high-impact Power BI dashboards that provide real-time visibility into business KPIs. Process Optimization: Utilize Smartsheet to build automated workflows, and bridge the gap between operational tasks and data reporting. Stakeholder Collaboration: Act as a translator between technical data teams and business units to ensure data solutions meet actual commercial needs. Continuous Improvement: Proactively identify trends or inefficient processes, driven by an inherent curiosity to solve problems before they are flagged by leadership. Required Skills & Qualifications Technical : Proficiency in Power BI (DAX/Power Query) and Smartsheet (Control Center/Automations). Data Architecture : Experience working with Data Lakes (e.g., Azure Data Lake, AWS S3, or Snowflake). Analytical Tools : Strong SQL skills for data extraction and a solid grasp of Excel. Soft Skills : High level of motivation and a self-starter "driven" mentality. Problem Solving : A proven track record of curiosity-driven analysis - going beyond the "what" to find the "why". Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
PCI Pharma Services is seeking an Associate Director Validation in Stamullen, Ireland. This key role involves leading validation activities across multiple domains, managing a validation team, and ensuring compliance with regulatory requirements. Ideal candidates should have over 10 years of experience in validation, a degree in a relevant field, and strong communication skills. This position may require some travel. Join PCI in delivering life-changing therapies with a focus on equity and inclusion. #J-18808-Ljbffr
The Associate Director Validation is a key member of the Site Quality Leadership Team, responsible for leading the implementation and execution of validation activities across Process, Facility, Laboratory, Computer System Validation (CSV), Cleaning, and Equipment Development at PCI Ireland Pharma Services sites. Main Responsibilities Responsible for PCI Ireland validation design, strategy, compliance, and overall adherence to VMP. Communicating the strategy to site leadership and working closely with all functional departments to ensure the VMP is understood and adhered to. Ensuring all validation activities on site related to Facility, Laboratory Equipment, CSV, Processes (packaging and cleaning), and Data Integrity meet client expectations and regulatory requirements (HPRA/FDA). Define Validation KPIs and validation schedule; utilise SQDC to manage operations and provide weekly summaries to Quality Director. Manage and develop the validation team, including training, coaching, and HR‑related activities such as performance reviews. Act as a key member of the site leadership team, flagging concerns and coordinating with Engineering, Production, NPI, QC, and other departments. Apply risk methodology, remain pragmatic, and be solution oriented to ensure validation compliance across sites. Serve as a member of the Corporate Centre of Excellence, sharing best practices and collaborating with sister sites to deliver a unified PCI experience. Maintain and review the periodic and annual validation plan; report slippages through the SQDC model and introduce Continuous Process Verification. Generate validation templates, protocols, and documentation for computer systems, facilities, equipment, and processes in line with ALCOA+ principles. Maintain documentation for cleaning validation in line with industry best practice. Execute validation activities with minimal supervision alongside Technical, Production, and Engineering functions. Manage tooling validations and the associated documentation. Ensure strict implementation of validation procedures and timely, accurate completion of all documentation. Support complaint investigations, deviation investigations, and change controls as required. Lead ad‑hoc projects to meet business needs within the scope of responsibilities. Identify opportunities for process and procedural improvement. Drive good practice across the site and continually improve the validation system. Essential Requirements Bachelor’s or associate degree in Validation/Technical Engineering or Science. +10 years’ experience in Validation across Qualifications and Process Validation. Excellent communication and presentation skills, able to articulate risk‑based strategy to planners, customers, and senior management. Experience with QMS systems. Proven track record of delivering results through project management. Clear goal orientation, communication, and progress monitoring to meet predefined targets. Ability to manage multiple tasks and set priorities. Strong problem‑solving and troubleshooting skills; proactive approach to managing problems. Self‑motivated, results‑driven, adaptable, and collaborative. Proficiency in Microsoft Office (Excel, PowerPoint, Word, etc.). Some travel required for business purposes. Customer‑facing experience. Ability to work in a fast, dynamic environment while adjusting to unexpected constraints. Passion for results: drive, high energy, the ability to work under pressure and deliver results; action‑oriented approach; ability to overcome obstacles. Decision‑making ability to identify issues, problems, and opportunities. Strong insight into Pharma/Medical Device guidelines relating to regulatory and quality requirements. Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies, and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
PCI Pharma Services in Leinster, Ireland is looking for a Data Analyst to provide data analytics and visualization solutions. The role involves designing Power BI dashboards, optimizing processes using Smartsheet, and querying large datasets to identify trends. Candidates should have proficiency in Power BI, Smartsheet, and SQL, and demonstrate a strong problem-solving attitude. This position promises an engaging environment where curiosity and motivation are key to driving data-driven decisions. #J-18808-Ljbffr
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI Our investment is in people who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Description Job Title Receptionist / Administrator Department Finance Division / Section Finance Accountable To Office Manager Main Purpose Of Job The Receptionist / Administrator is responsible for managing front desk operations while providing ad‑hoc administrative support to the site. This role ensures a professional and welcoming environment for employees, visitors, and clients, while also assisting with ad‑hoc hospitality events and projects as they arise. Key Responsibilities Greet and assist visitors, employees, and clients in a professional and friendly manner. Manage the day‑to‑day administration of a busy reception area, including phones, couriers, and post. Answer and direct phone calls, emails, and general inquiries efficiently. Maintain site security by issuing, monitoring, and collecting work IDs, and updating visitor logs. Set up new hires on access systems, including badge creation, access control, and locker allocation. Monitor and order office stationery and canteen supplies across the site. Prepare, edit, and format documents, reports, and presentations as required. Support business travel arrangements through third‑party providers or directly for employees. Assist in organising company events, training sessions, and meetings. Coordinate meeting room bookings and schedules. Carry out additional duties and projects as assigned by management. Key Requirements Previous experience in a receptionist or administrative role. Strong interpersonal and communication skills. Proficiency in Microsoft Office Suite (Word, Excel, Outlook). Excellent organisational and multitasking abilities. High level of discretion and confidentiality. Ability to work independently and as part of a team. Qualifications A diploma or degree in Business Administration, or a related field is desirable. Experience in a similar role within a corporate or professional setting. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future. Equal Employment Opportunity (EEO) Statement PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life‑changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr
A global biopharma services provider in Ireland is seeking a production team member for the Thursday-Saturday night shift. The candidate will be responsible for ensuring product quality, adhering to safety procedures, and completing necessary documentation. This role requires flexibility and teamwork within the production environment, contributing to both quality assurance and operational efficiency. #J-18808-Ljbffr
