A global healthcare company in Dublin is seeking a Global Supply Planning Manager for a 12-month contract. The role involves developing optimal supply plans, analyzing data for improvements, and ensuring compliance with regulations. The ideal candidate will have experience in supply chain methodologies, a bachelor's degree in a related field, and strong skills in ERP systems like SAP. This position offers competitive benefits and opportunities for career development in a rapidly expanding environment. #J-18808-Ljbffr
Global Supply Planning Manager (12‑Month Contract) Join to apply for the Global Supply Planning Manager (12‑Month Contract) role at Grifols . Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that has been working to improve health and well‑being since 1909. We are leaders in plasma‑derived medicines and transfusion medicine, developing, producing and marketing innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, teams and culture. We are committed to equal employment opportunities that foster an inclusive environment. Position Summary Reporting directly to the Global Supply Planning Manager, the Global Supply Planning Manager will ensure an optimal supply plan and on‑time availability of products to support sales while meeting operational targets. The position ensures effective planning, compliance with company policies, and applicable regulatory requirements (e.g., cGMP, GAAP). Other key responsibilities include analysing data and making recommendations to manage gaps, opportunities, process improvement and supporting budgeting activities. The position will primarily be based in Grifols Worldwide Operations, Dublin, Ireland, with travel expected in line with business needs to other Grifols locations. What You Will Be Doing Focus on strategic planning and execution of the best supply plan for the business, taking into consideration commercial and industrial feedback. Make or recommend appropriate decisions consistent with strategic direction. Organise key activities and support the Global Supply Planning Director in key activities and processes as required. Act as a member of all cross‑functional project teams, providing guidance, insight, and recommendations relative to the goals and objectives of the function. Serve as the main point of contact for cross‑functional integration and consult on enhancements or future integrations. Act as an escalation point for non‑routine issues/decisions. Direct the development of strategic programmes/initiatives and evaluate performance against metrics. Serve as a team representative in strategic planning and operating discussions with senior leadership. Develop, execute, maintain and report on detailed supply and demand inventory balance, and/or supply plan achievements against budget and/or approved revised plans for all products manufactured or processed through Grifols multiple biopharma locations. Work closely with factory leads to develop, prioritise and manage monthly supply plan key issues or topics, leading projects supply and consolidated protein level information. Work closely with Global Demand and Industrial leads to ensure alignment between supply and demand. Provide timely and accurate supply scenario analyses and inventory reports to management as required. Participate and lead from global supply planning area on implementation of a singular Grifols global integrated business planning process to deliver seamless supply chain management solutions in terms of cost, time and service. Develop and report on KPIs including material and product aging, at‑risk batches, batch release cycle time; identify and rectify issues, and/or recommend solutions for improvement. Maintain a quality presence to ensure compliance with all regulatory requirements. What We Are Looking For An in depth understanding of the fundamentals of planning and inventory control; Lean, Six Sigma, exposure to theory of constraints preferred. Strong technical skills in ERP navigation and reports; specific experience with SAP is preferred. Project management skills. Working knowledge and understanding of cGMPs, FDA regulations and industry guidelines. Self‑starter with strong work ethic, common sense, and ability to work effectively with multiple and changing priorities. Strong organisational, analytical and problem‑solving skills with the ability to make structured decisions on a routine basis. Proactive, results‑oriented, and strong attention to detail. Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment. Computer literacy; MS Office with advanced proficiency in Excel required. Bachelor’s degree in Supply Chain Management, Industrial Engineering, Business, Science or closely related discipline is required; CPIM certification preferred. Master’s degree in the same fields or closely related discipline preferred. Minimum of four years’ supply planning, forecasting or related experience in supply chain methodologies, preferably in a pharmaceutical, GMP or FDA/EU regulated environment. Benefits Highly competitive salary. Group pension scheme – contribution rates are 1.5 % / 3 % / 5 % / 7 % and company will match. Private medical insurance for the employee. Ongoing opportunities for career development in a rapidly expanding work environment. Succession planning and internal promotions. Education allowance. Wellness activities – social activities such as Padel, summer events. We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we’re excited to hear from you. Location EMEA : Ireland : Dublin : Grange Castle (Dublin). Seniority level Mid‑Senior level. Employment type Contract. Job function Management and Manufacturing; Industries: Pharmaceutical Manufacturing and Medical Equipment Manufacturing. #J-18808-Ljbffr
A global healthcare company is seeking a Validation Engineer Technical Lead in Dublin to lead validation projects and ensure compliance with quality standards. The ideal candidate will have a degree in Science/Engineering and at least 5 years of validation experience in the pharmaceutical sector. Key responsibilities include authoring validation plans, representing the validation team during audits, and executing validation activities across equipment and processes. The role offers a competitive salary and full-time employment with career development opportunities. #J-18808-Ljbffr
Join to apply for the Validation Engineer Technical Lead role at Grifols Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Position Summary The Technical Lead for Validation will represent the Validation team in leading validation projects and driving strategic initiatives. This role is responsible for planning and implementing validation strategies for major capital projects and serving as the primary Validation representative in technical forums, including internal and external audits. Key responsibilities include authoring, reviewing, and executing Validation Plans, Protocols, and Reports for the new GWWO facility, ensuring full compliance with global and local quality standards and validation procedures. Initial focus areas will include Equipment Qualification, Utilities, Process Validation, Aseptic Process Validation, and Cleaning Validation. What You'll Do Write, review and execute Validation Protocols and Reports (for Equipment, Steam sterilisation, Utilities, Processes, Cleaning, and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards. Review change controls and assess impact of changes that affect validated systems and define validation requirements. Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA. Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures. Supporting validation activities including review of documentation and hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc.) to ensure equipment meets current GMP requirements and industry standards. Maintain the Site Validation Master Plan (VMP) and associated Project VMP’s, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co‑ordinate Re‑Validation activities as required. Completion of risk assessments, closure of corrective and preventive actions and deviations. Develop alternative solutions to problems, handle highly complex problems independently. Demonstrates technical knowledge and ability to adapt to changing circumstances. Works with other departments Operations, Quality, and Maintenance to lead qualification and validation efforts in support of site projects. Performs other validation associated activities as defined by Manager or Director. Evaluate and analyse validation data collected during projects, verify adequacy of the information and compliance with regulations. Performs reviewed activities in protocols. May have signature authority for Validation Manager with appropriate qualification. What You'll Bring Qualifications Project Management Experience Hands‑on knowledge of execution of Validation Experience in a Quality or Validation Role within Pharma sector Experience with Software validation for manufacturing Experience in Cleaning, Process and Aseptic Process Validation. Excellent Technical Writing and analytical skills. Familiarity with cGMPs and industry and federal guidelines required. Experience with Word, Excel and Access computer applications. Strong interpersonal skills for interactions with other departments. Degree in Science/Engineering and/or Min 5 years Validation experience Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves Familiarity with ISO-14644 (Cleanrooms and Associated Environments) Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products) Experience within aseptic manufacturing environment Our Benefits Include Highly competitive salary Group pension scheme – Contribution rates are (1.5%/3%/5%/7%) and company will match Private Medical Insurance for the employee Ongoing opportunities for career development in a rapidly expanding work environment Succession planning and internal promotions Education allowance Wellness activities – Social activities e.g. Padel, Summer Events We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you. Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3 Seniority level Mid‑Senior level Employment type Full‑time Job function Quality Assurance Pharmaceutical Manufacturing and Medical Equipment Manufacturing Referrals increase your chances of interviewing at Grifols by 2x #J-18808-Ljbffr
A global healthcare company based in Dublin is seeking a CSV Validation Engineer to lead validation strategies for capital projects. This role involves ensuring compliance with global quality standards while authoring validation protocols and representing Validation in audits. Candidates should have project management experience, familiarity with GxP regulations, and at least 2 years in equipment qualification. This position offers competitive salary and ongoing career development opportunities. #J-18808-Ljbffr
CSV Validation Engineer – Grifols Join to apply for the CSV Validation Engineer role at Grifols . Get AI-powered advice on this job and more exclusive features. At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment. Position Summary The CSV Validation Engineer serves as the subject matter expert (SME) within the Validation team, leading validation strategies for major capital projects. The role involves planning and executing validation activities for new software, automated equipment, and enterprise or cloud-based systems (SaaS). The engineer will represent Validation in technical forums, internal and external audits, and act as a site champion for data integrity. Responsibilities include authoring and reviewing validation plans, protocols, and reports while ensuring compliance with global and local quality standards. Initial focus areas will include automation and CSV, supporting GxP compliance and operational excellence. What You’ll Do Write, review and execute Validation Protocols and Reports (for equipment, software/automation, and enterprise software systems) ensuring compliance with all relevant global and local quality and validation procedures/standards. Review change controls and assess impact of changes that affect validated systems and define validation requirements. Represent Validation at internal and external audits by regulatory agencies, including HPRA and FDA. Generate and review CSV project documentation (User Requirement Specifications, validation protocols, reports, etc.) and Standard Operating Procedures. Support validation activities including review of documentation and hands‑on execution of validation activities (FAT, SAT, IQ, OQ, PQ, UAT, etc.) to ensure equipment/software meets current GMP requirements and industry standards. Maintain the Site Validation Master Plan (VMP) and associated Project VMPs, defining the validation approach for each piece of equipment, system, process, and the requalification requirements including study requirements and frequency. Execute/co‑coordinate re‑validation activities as required. Complete risk assessments and close corrective and preventive actions. Develop alternative solutions to problems, handle highly complex problems independently, and collaborate with Operations, Quality, IT and Maintenance to lead qualification and validation efforts in support of site projects. What You’ll Bring Project Management Experience. Hands‑on knowledge of validation execution. Experience validating MES/EBR/LIMS and other enterprise systems (SaaS/cloud‑based). Experience with automated equipment (SCADA/BMS/DCS). Solid knowledge of GxP, FDA 21 CFR Part 11, EU Annex 1 and ISPE GAMP 5 guidelines. Experience in a Quality or Validation role within the pharma sector. At least 2 years of equipment qualification experience (GAMP, equipment life‑cycle FAT, SAT, DQ, QRM, IQ, OQ, PQ) and experience performing data integrity assessments and data mapping. Excellent technical writing and analytical skills. Familiarity with cGMPs and federal guidelines. Experience with Word, Excel and Access. Strong interpersonal skills for interactions with other departments. Degree in Science/Engineering and/or ≥ 4 years CSV/CSA validation experience. Experience representing client companies during internal (corporate) and external (FDA, HPRA) audits. Experience within aseptic manufacturing environment. PCS/DCS and automation experience. Key Competencies Project Management skills. Computer System Validation and CSA knowledge. Commissioning and Qualification. Documentation (SOPs, protocols, reports). Data Integrity, data mapping and governance (ALCOA principles). Auditing. Strong communication/presentation skills during audits. Familiarity with IT infrastructure and applications in pharmaceutical/biopharmaceutical environments. Problem‑solving and organisational skills. Our Benefits Include Highly competitive salary. Group pension scheme with company matching. Private medical insurance. Ongoing career development opportunities. Succession planning and internal promotions. Education allowance. Wellness activities (social events, Padel, summer events). Location: Grange Castle International Business Park, Grange, Co. Dublin, D22 K2R3. Be part of a global company that has been improving healthcare since 1909. We encourage everyone who meets the qualifications to apply. #J-18808-Ljbffr
A global healthcare company in Dublin is seeking a QA Manufacturing Specialist to ensure compliance in the aseptic manufacturing of albumin. The ideal candidate will have GMP experience and a background in pharmaceutical sciences. This role includes performing facility audits and supporting regulatory compliance in a dynamic environment. The position offers competitive salary and opportunities for career development. #J-18808-Ljbffr
QA Manufacturing Specialist Join to apply for the QA Manufacturing Specialist role at Grifols Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Summary The QA Manufacturing Specialist is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). Reporting directly to the QA Manufacturing Supervisor of Grifols Worldwide Operations (GWWO), the successful candidate will focus on the aseptic compliance aspects of Albumin Manufacturing, both purification/formulation and aseptically filled product, ensuring that operations are performed in accordance to the defined procedures, maintaining GxP standards to provide assurance of product quality and patient safety. They will operate within a QA shop floor capacity and will be an ‘on‑the‑ground’ key stakeholder of all core manufacturing departments, including the wider QA network, manufacturing, maintenance, automation, and supporting functions. What will you be doing Ensure the quality of the work is maintained and inspection‑ready in accordance with internal and external cGxP requirements and expectation. Ensure adherence to GMP, EU Annex 1, FDA, and other applicable regulatory guidelines. Support the cross‑function readiness for batch certification, ensuring all documentation related to the team is finalised within a timely manner. Ensure personal compliance with all Training and Health & Safety requirements, in accordance with company policy. Support the team’s overall performance with regular interaction with the wider site departments, as defined via tier/triage‑structures. Support the team’s general direction to ensure the team is successful in handling day‑to‑day operations, in alignment with the functional directives. Any other duties as required, following consultation with the post holder. Quality Activities Performing daily GEMBAs and facility walk‑through audits of the manufacturing facility, inclusive of Grade A, B, C, and D classified areas, ensuring all functions are maintaining GMP compliance to defined procedures and working practices. Performing routine observations of batch‑related critical activities within the manufacturing processes (purification and aseptic filling), ensuring GMP compliance to defined procedures and batch records. Support the manufacturing in‑process control (IPC) and end‑of‑batch reconciliation processes, ensuring batch‑related manufacturing operations are compliant to the defined procedures and batch records. Support in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area. Who you will be? Essential Working experience within a Sterile Pharmaceutical GMP‑regulated facility. Working experience in GMP cleanrooms, inclusive of Grade A, B, C, D classified areas and associated controls in‑situ, utilizing RABS technology. Working experience with QMS processes, both paper‑based and electronic systems (e.g., Batch Records, LIMS, Veeva Vault, Trackwise, etc.). Understanding of GMP regulation and guidance, notably Annex 1 ‘Sterile Manufacture’ and FDA Aseptic Guide. MS Office. Desirable Understanding of Albumin manufacture Purification and Aseptic Filling in a bag presentation. Verbal and written communication in Spanish and/or Catalan. Educational Qualifications Minimum 3 years’ experience in a pharmaceutical manufacturing environment with EU GMP regulation AND Bachelor or Master’s degree in Pharmaceutical Sciences or Administration. OR Minimum 5 years’ experience in aseptic manufacturing within a Quality or Manufacturing capacity, preferably utilizing RABS technology (Grade A & B). What We Offer Highly competitive salary Group pension scheme – Contribution rates are (1.5% / 3% / 5% / 7%) and company will match. Private Medical Insurance for the employee (Irish Life). Ongoing opportunities for career development in a rapidly expanding work environment. Succession planning and internal promotions. Education allowance. Wellness activities – Social activities e.g. Padel, Summer Events. We understand that self‑doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we’re excited to hear from you. Location EMEA : Ireland : Dublin : Grange Castle (Dublin) #J-18808-Ljbffr
