A leading biopharmaceutical company based in Limerick is looking for a Sr Facilities Engineer to provide engineering support, manage HVAC systems, and oversee small projects. The ideal candidate should possess a Level 8 in an engineering discipline with 3+ years of relevant experience. Responsibilities include designing clean utilities, conducting troubleshooting, and preparing design documentation while ensuring compliance with safety regulations. This full-time position offers a dynamic work environment. #J-18808-Ljbffr
Job Title Sr Facilities Engineer Location BioSpace, Limerick, County Limerick, Ireland Overview Within this role you will be responsible for providing engineering support, troubleshooting and subject‑matter expertise to the Facilities Operations, Utilities and HVAC teams. You will design, specify and commission new and renovated biopharmaceutical utilities and HVAC equipment, and manage small‑to‑mid‑size projects related to utilities and HVAC equipment & services. Responsibilities Designing and specifying cGMP clean/grey utilities, HVAC equipment, piping, ducting and controls Managing small‑to‑mid‑size projects related to utilities and HVAC equipment and services Conducting troubleshooting for complex plant equipment issues and related systems, identifying and recommending corrective actions Assisting in design review, site acceptance and installation of equipment Supporting the QA validation department by preparing design documents and assisting in protocol execution Assisting in investigations of utility systems, control system anomalies and safety incidents Implementing corrective/preventative actions for existing equipment and maintenance processes Preparing engineering evaluations and test plans, and executing modification change‑control documentation Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications for planning and maintenance Supervising mechanical, electrical and automation contractors Maintaining a clean and safe working environment by enforcing procedures, policies and regulations Maintaining company reputation by ensuring compliance with all relevant laws, policies and regulations Qualifications You possess logical troubleshooting and problem‑solving skills You have good written, verbal and interpersonal communication skills and can interact effectively cross‑functionally You have strong analytical and organisational skills To be considered for this opportunity you must hold a level 8 within an engineering discipline or equivalent with 3+ years of engineering experience preferred. For the Senior Engineer, 5+ years of relevant industry experience is required. Direct experience with utilities systems (clean/grey) or HVAC is preferred. Job Details Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Management and Manufacturing Industries: Internet News #J-18808-Ljbffr
A leading biotechnology firm in County Limerick is seeking an experienced auditor to assist with management and to ensure auditors are properly trained. This role involves planning and conducting audits, maintaining compliance with regulatory standards, and collaborating with various departments. The ideal candidate should have over 8 years in the Biotech/Pharmaceutical industry and possess strong leadership and communication skills. This position requires approximately 50% global travel. #J-18808-Ljbffr
BioSpace Limerick, County Limerick, Ireland Responsibilities Developing an effective compliance framework for the Supply Chain department through the development and implementation of appropriate compliance related policies and procedures. Acting as a liaison with onsite quality and regulatory groups to define and address all issues of non‑compliance. Facilitating all reviews and revisions of all Supply Chain department related SOPs, plans and policies for each group within the department. Providing support, information and assistance to individual groups and supervisors with the initiation, review, submission and follow‑up of documents such as CCs, NOEs, DNFs, impact statements and corrective action plans. Driving a proactive compliance environment through completion of self‑audits, knowledge transfer and education of compliance related items. Leading and participating directly in the investigation process and reviewing investigation reports. Ensuring Corrective & Preventative Actions are appropriate, implemented as planned and have the intended efficiency. Leading and managing Change Controls for Supply Chain. Providing coaching to direct reports, including employee development plans, and fostering a healthy work environment where employees feel valued and respected. Role Requirements Previous experience in compliance and project management within a cGMP environment. The ability to manage multiple, complex projects and changing priorities. Effective decision‑making capabilities and ability to work in a team environment. The ability to empower and direct a team, supervise and mentor staff. Strong analytical skills and the ability to communicate details clearly and effectively. Excellent attention to detail, time management and interpersonal skills. To be considered for this opportunity you should have a BS/BA/BEng in Business, Supply Chain Management or Science background and 7 years of relevant experience in a cGMP environment or an equivalent combination of education and experience. Benefits We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter. EEO Statement Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. #J-18808-Ljbffr
A leading life sciences company in Limerick, Ireland, is seeking a Compliance Manager to develop and implement compliance frameworks within the Supply Chain department. The ideal candidate will have 7 years of experience in a cGMP environment and a degree in Business or Science. Key responsibilities include managing compliance-related policies, leading investigations, and providing coaching to staff while fostering an effective team environment. Comprehensive benefits are offered to all employees. #J-18808-Ljbffr
BioSpace Limerick, County Limerick, Ireland Responsible for assisting management with ensuring auditors have the education, experience and/or training necessary to be able to perform audits, and assisting with the maintenance and continuous improvement of the auditor training program. Responsible for planning, coordinating and performing pre-, during and post-audit activities for assigned audits. Extensive knowledge of USA and EU GxP regulations is required. Essential Duties and Responsibilities Maintain professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.). Monitor industry trends with respect to regulatory agency findings, expectations and warning letters. Lead and/or participate in the development and maintenance of department processes and procedures to ensure compliance with current regulatory requirements. Assist management with the maintenance and continuous improvement of the auditor training program, oversight of the training and qualification of auditors, and the development and maintenance of continuing auditor education. Ensure written and departmental procedures, timelines and requirements are followed and met. Assist with audit scheduling and audit assignments as needed. Assist with the oversight, selection, training, onboarding and assessment of proxy auditors. Perform review of audit documentation (audit reports, audit responses, extensions, etc.) for purposes of training, peer review, approval and/or audit closure. Perform supplier/external audits and evaluate systems, processes, procedures and records against applicable GxPs and audit criteria. Collaborate with Procurement, External Manufacturing, Quality, audit clients and other stakeholders with respect to supplier/external audits. Perform and maintain all required training and annual GMP training within required timelines. Perform required lead auditor or support auditor activities as applicable for assigned audits. Prepare written audit reports and documents in accordance with company and department procedures and requirements; ensure the quality and accuracy of all audit documentation; ensure timelines for assigned audits are met. Provide guidance and support in the development of corrective and preventive actions based on GxP requirements and industry standards. Participate in IOPS inspection readiness, inspections/partner audits, and internal audits as needed. Perform other duties and responsibilities as assigned by management. This position requires approximately 50% travel, globally. This Role Might Be For You If You are adaptable and willing to travel globally. You possess strong leadership qualities. You have excellent communication and collaboration skills. You demonstrate expertise in regulatory compliance. Education And Experience BS/BA with 8+ years of related experience in Biotech/Pharmaceutical industry; other relevant experience may be considered in lieu of degree or equivalent combination of education and experience. A minimum of 8+ years of Quality Management experience in a GMP environment with prior supplier auditing experience; experience in aseptic filling operations is preferred. Do you want a career where you can thrive, grow, and make an impact? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit Regeneron benefits . For other countries specific benefits, please speak to your recruiter. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. #J-18808-Ljbffr
BioSpace Limerick, County Limerick, Ireland As a QC Analyst in HPLC Chemistry you will perform a wide variety of chemical or biological analyses on products, in-process materials, or stability samples in support of the company’s quality program. Typical Responsibilities Gathering data and documenting test results Reviewing test results to ensure compliance with standards and reporting any quality anomalies Complying with all pertinent regulatory agency requirements Participating in required training activities Maintaining laboratory supplies Conducting testing on in-process, product, stability, and/or research samples Writing and revising control test procedures and SOPs Completing test records and reviewing data Calibrating or verifying calibration of instruments/devices prior to use Interacting with outside customers or functional peer groups May be responsible for maintaining a specific project May devise or develop new analytical methods and techniques May assist in validation and method transfer of methods May be involved in establishing the transfer of methodology from R&D This Role Might Be For You If You have current or prior experience working with HPLC in a regulated environment You enjoy working a shift pattern You have a proven ability to work independently or as part of a team You possess strong trouble‑shooting and problem solving skills You have strong attention to detail & excellent written and oral skills To be considered for this opportunity you should have a BS/BA in Life Sciences or related field. Minimum of 2 years experience in QC. HPLC/UPLC and Empower required. Experience in SE‑UPLC, peptide and glycan assay desirable. Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries specific benefits, please speak to your recruiter. Position Details Seniority level: Entry level Employment type: Full-time Job function: Quality Assurance Industry: Internet News Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. #J-18808-Ljbffr
A leading life sciences company in County Limerick, Ireland, is looking for a Quality Control Analyst with expertise in HPLC Chemistry. The successful candidate will perform chemical analyses, maintain laboratory supplies, and ensure compliance with quality standards. Applicants should possess a BS/BA in Life Sciences along with a minimum of 2 years of experience in Quality Control, familiarity with HPLC, and strong troubleshooting skills. Competitive benefits are available. #J-18808-Ljbffr
Principal GMP Data Governance Business Partner (Data Integrity) BioSpace, Limerick, County Limerick, Ireland Within this role you will be responsible for the implementation of data governance (DG) standards, policies and procedures into business operations. You will be a site expert on Data Governance, supporting the Regeneron IOPS Data Governance and Integrity program. Typical Responsibilities Implementing the Data Governance standards, policies and procedures within allocated areas of the business. Serving as the key DG contact and providing support and advice to the allocated business unit on DG priorities and action plans. Assessing current policies and processes of the business unit and coordinating the achievement of local KPIs. Conducting regular data audits and assessments to identify DG issues and preparing the business unit for DG auditing and inspections. Working with DG Business Partners, Technical Experts and ECM Experts to deliver the DG plan and provide feedback for continuous improvement. Encouraging a culture of quality and Data Governance within the organization and promoting the importance of DG across all departments. Driving communication and collaboration between stakeholders to ensure effective DG practices. Encouraging continuous improvement by actively seeking feedback and supporting initiatives designed to improve data quality and governance. Leading and supporting initiatives to embed DG principles into the company’s core values and everyday practices. Qualifications Knowledge of relevant regulations and guidelines (e.g., GDPR, FDA, EMA, WHO). Proven success in implementing and managing policies in regulated environments. Strong communication and collaboration skills. Skilled in stakeholder management and influence. Experience with quality systems and change management. To be considered for this role you must hold a BA/BS degree and 7+ years of professional experience or an equivalent combination of education and experience in pharmaceutical/FDA regulated work areas such as data management & operations, quality assurance, compliance, manufacturing operations, quality control, or IT. Benefits Regeneron is an equal opportunity employer and offers comprehensive benefits including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Company’s business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications, etc. #J-18808-Ljbffr
A leading biotechnology firm in Limerick is seeking a Principal GMP Data Governance Business Partner to implement data governance standards and drive compliance within the organization. The ideal candidate will have over 7 years of experience in pharmaceutical regulated environments, coupled with strong communication skills and a deep understanding of regulatory guidelines. This role offers a comprehensive benefits package including health programs and annual bonuses. #J-18808-Ljbffr
