A leading biopharmaceutical company located in Limerick, Ireland is seeking a Senior Project Engineer to design and commission biopharmaceutical process equipment. This role requires overseeing projects, collaborating across departments, and ensuring compliance with regulations. Ideal candidates will have a degree in engineering and over 5 years of experience with biopharmaceutical equipment. The position offers full-time employment and a comprehensive benefits package tailored to the location. #J-18808-Ljbffr
BioSpace – Limerick, County Limerick, Ireland Senior Project Engineer BioSpace is seeking a Senior Project Engineer to design, specify, and commission new and renovated biopharmaceutical process equipment. The role includes engineering support, problem‑solving for existing equipment and manufacturing processes. Typical Responsibilities Designing and specifying cGMP process equipment, piping, and controls. Managing small‑to‑mid‑size projects related to process equipment and manufacturing. Assisting in the design review, site acceptance, and installation of equipment. Preparing piping and instrumentation diagrams (P&IDs) and other related drawings. Developing Process Flow Diagrams (PFDs) for manufacturing processes. Supporting the QA Validation department by preparing design documents and assisting in protocol execution. Reviewing and approving lifecycle documentation, cleaning validation protocols, and summary reports. Assisting with investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents. Assisting management with tracking of department throughput and efficiency. Representing the engineering department at cross‑functional meetings. Supervising direct reports as needed. Implementing corrective/preventive actions for existing equipment and manufacturing processes. Preparing engineering evaluations and test plans, and executing change control documentation. Supervising mechanical, electrical, and automation contractors as needed. 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 should have a BS/BEng or higher in chemical/process/mechanical engineering with 5+ years of related experience. Direct experience with biopharmaceutical process equipment is preferred. Relevant experience may substitute for education. This Role May Be For You If Excellent technical and analytical skills. Skilled at problem‑solving and continuous improvement. Strong communication and collaboration skills. Adaptable and able to work in a fast‑paced, regulated environment. Seniority level Mid‑Senior level Employment type Full‑time Job function Engineering and Information Technology Internet News BioSpace offers a comprehensive benefits package tailored to location. For more details on benefits, please consult 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. #J-18808-Ljbffr
A biopharmaceutical company in Limerick is seeking a Senior Facilities Engineer to provide engineering support for the Utilities and HVAC teams. You will manage projects, troubleshoot complex systems, and assist in designing and commissioning biopharmaceutical utilities. The ideal candidate should have strong problem-solving skills, a degree in engineering, and extensive experience with utilities systems or HVAC. This role offers a competitive salary and a chance to grow in a dynamic environment. #J-18808-Ljbffr
A leading biotech company in County Limerick is seeking an Associate Biotech Production Specialist to join their Manufacturing Team. This role involves monitoring production processes, participating in equipment validation, and adhering to strict safety and GMP guidelines. Candidates should have a BS/BA in Life Sciences, excellent communication skills, and the ability to work effectively within a team in a dynamic environment. Competitive salary and comprehensive benefits package are offered. #J-18808-Ljbffr
Within this role you will be working as part of the Manufacturing Team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors. As an Associate Biotech Production Specialist, a typical shift might include, but is not limited to, the following: Working as part of the Manufacturing team to carry out tasks in line with the production schedule as directed by Team Leads and Supervisors Monitoring production processes Participating in equipment start-up, commissioning, and validation activities Assisting with troubleshooting in case of equipment failure Performing manufacturing level maintenance on equipment Adhering to safety and GMP (Good Manufacturing Practice) requirements at all times when carrying out tasks Performing equipment cleaning, preparation and execution as well as completing associated documentation Performing various tests and in-process sampling Reviewing, editing and revising completed batch records, logbooks, and SOPs in accordance with cGMP standards Maintaining housekeeping in designated area and adhering to the clean standards of the facility This Role Might Be For You If You possess excellent verbal and written communication skills You enjoy problem solving You demonstrate a can-do attitude You are proficient in Microsoft Word, Excel, PowerPoint, and Outlook You demonstrate an ability to work within a successful team You can adapt to a changing environment and have the ability to adhere to a schedule To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field. Relevant experience may be substituted in lieu of the educational requirement. Our site operates on a 24/7 basis, and we offer a number of different shift working patterns that could fit with your lifestyle. What is on offer? You will be supported through a comprehensive onboarding programme which will include formal classroom learning along with on-the-job training all within an encouraging environment. Benefits Ensuring the health and well-being of our people is just as meaningful to us as the patients our life-transforming medicines serve. That's because we know caring for people around the globe should start with supporting our employees through our comprehensive compensation and benefits offering that includes: Competitive Salary Shift Premiums Annual Bonus Stock Schemes Employer Pension Contributions Education Assistance Generous Annual & Flexible Leave Programs Competitive Private Medical, Dental & Vision Plans Career & Personal Development Wellness Programs – Onsite Gyms & Fitness Classes Concierge Services Onsite Beauty Therapist / Barber / Car Valet Community Volunteering Employee Interest Groups / Employee Teams & Clubs Employee & Family Events Does this sound like you? 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! 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. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regenerons roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regenerons on‑site policy and expectations for your role and your location. 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
Sr Facilities Engineer BioSpace, Limerick, County Limerick, Ireland 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-sized projects relating to utilities and HVAC equipment & services. Typical responsibilities include, but are not limited to: Designing and specifying cGMP clean/grey utilities and HVAC equipment, piping, ducting, and/or controls Managing small-to-mid sized projects related to utilities and HVAC equipment and services Conducting troubleshooting for complex issues with plant equipment and associated systems, identifying and recommending corrective actions Assisting in the 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, and control system anomalies as well as safety incidents Implementing corrective/preventative actions for existing equipment and maintenance processes Preparing engineering evaluations and test plans for and executing modification change control documentation Interpreting P&IDs, equipment/system layouts, wiring diagrams and specifications in planning and performing maintenance and repairs Supervising mechanical, electrical, and automation contractors Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations Maintaining company reputation by enforcing compliance with all relevant laws, policies and regulations Qualifications and skills This role might be for you if you possess logical troubleshooting and problem‑solving skills, good written, verbal and interpersonal communication skills and the ability to effectively interact cross‑functionally, and 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 experience in engineering (preferred). For the Senior Engineer you must have 5+ years of relevant industry experience. Direct experience with utilities systems (clean/grey) or HVAC is preferred. Background checks will be conducted in accordance with the law of the country where the position is based. Equal Opportunity Employer Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, 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 otherwise qualified applicants for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. #J-18808-Ljbffr
A leading biotech company is seeking a Principal GMP Auditor to remotely oversee and conduct various audits. The role requires excellent regulatory compliance knowledge and 8+ years of experience in the Biotech/Pharmaceutical industry. Responsibilities include maintaining audit criteria knowledge, training auditors, and managing supplier audits. The ideal candidate exhibits strong leadership and communication skills, and must be willing to travel globally. This is a full-time position based in Limerick, Ireland. #J-18808-Ljbffr
Job Details Title: Principal GMP Auditor‑Remote Location: BioSpace Limerick, County Limerick, Ireland Remote: Yes Travel Approximately 50% global travel. Responsibilities Maintain professional expertise and knowledge of audit criteria, internal policies, and applicable regulations, standards, and guidelines (e.g., CFR 21, Eudralex Volume 4, ISO standards, ICH, WHO, IPEC). 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. Ideal Candidate 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. Qualifications 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. Seniority level Mid‑Senior level Employment type Full‑time Job function Accounting/Auditing and Finance Industries Internet News Benefits & Legal 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
Senior/Principal Instrumentation Engineer BioSpace – Limerick, County Limerick, Ireland Within this role you will be responsible for specifying instrumentation for biopharmaceutical process & utilities systems and for supporting all aspects of the site calibration program. You will evaluate new instrumentation for functional equivalence to existing instrumentation, author and maintain configuration specifications and standards for cGMP manufacturing instrumentation. Typical Responsibilities Understanding common process & utilities instrumentation, including load cells, pressure transmitters/gauges, pH sensors, dissolved oxygen sensors, temperature sensors, mass flow meters, UV analyzers, conductivity sensors, TOC analyzers and level sensors. Evaluating & specifying cGMP instrumentation for new installations & upgrading existing instrumentation with additional functionality, including instrument components & spare parts. Acting as the technical SME for the site calibration program, providing guidance to calibrations operations team and supporting regulatory body inspections and audits. Evaluating new instrumentation for functional equivalence to existing instrumentation that has become obsolete. Implementing corrective/preventative actions for existing instrumentation. Maintaining working knowledge of process automation control systems. Conducting troubleshooting and root‑cause analysis for complex instrumentation and associated systems. Creating and maintaining configuration specifications for cGMP manufacturing instrumentation. Assisting in the design review of equipment and approving supplier lists for instrumentation. Reviewing and approving wiring diagrams for instrumentation & associated control systems. Preparing engineering evaluations and test plans for change‑control documentation. Writing and executing test plans to demonstrate instrument suitability. Supervising engineering contractors, if required. Maintaining a clean and safe working environment by enforcing procedures, policies, and regulations. Maintaining company reputation by ensuring compliance with applicable regulatory authority requirements. Skills & Qualifications Logical troubleshooting and problem‑solving skills. Strong written, verbal and interpersonal communication skills with ability to interact cross‑functionally. Strong analytical and organisational skills. BEng/BS degree (or equivalent) with 5+ years experience for Senior Engineer level and 8+ years experience for Principal Engineer level. Experience with biopharmaceutical process & utilities systems is preferred. Other Information Seniority level: Mid‑Senior level Employment type: Full‑time Job function: Engineering and Information Technology Industries: 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. 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 biopharmaceutical company located in Limerick, Ireland is seeking a Senior/Principal Instrumentation Engineer responsible for specifying instrumentation for biopharmaceutical process and utilities systems. The role includes supporting the site's calibration program and evaluating new instruments. Candidates must have a degree and substantial experience, particularly in biopharmaceutical systems. This full-time position offers a mid-senior level opportunity within engineering and information technology. #J-18808-Ljbffr
