Initial Therapeutics, Inc. is seeking a Principal QA Specialist in Ireland to ensure IT systems and quality events are compliant. The role involves supporting IT-related change controls, engaging with IT processes to meet Quality System requirements, and reviewing SOPs. Applicants should have a BSc/BA/BEng in IT/Automation/Analytics with 5-7 years of experience, preferably in data integrity. The position emphasizes strong interpersonal skills and knowledge of regulatory requirements. #J-18808-Ljbffr
Working within the Quality Assurance organization this position is responsible for ensuring IT systems, programs and quality events are robust and compliant. The position will liaise with the IT and broader QA organizations to ensure all aspects of IT related programs are in compliance with regulatory agency expectations and internal company policies and procedures. As a Principal QA Specialist, a typical day might include the following: Supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programs Engaging with Corporate and IOPS IT ensuring IT processes and procedures meet Regenerons Quality System requirements Reviewing, editing and approving SOPs, deviation notifications, deviation investigations, and corrective actions Responsible for compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Collaborating, investigating and troubleshooting to determine solutions or recommendations for changes and/or improvements Participating and supporting the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives Supporting the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process Contributing information reflecting best practices, industry trends and recommendations for strategic plans to drives changes and improvements Communicating project and program status and metrics to Senior Management This role might be for you if you: Demonstrate strong interpersonal skills and can collaborate effectively Can balance changing priorities with a growing workload by communicating timely decisions Demonstrate knowledge of 21CFR11 and Annex 11 as well MHRA, FDA and WHO data integrity guidelines Have an understanding of the interdependencies of change management, deviation and continuous improvement Can work in a dynamic organization where innovative solutions are required to ensure a high-level of quality is achieved with aggressive timelines To be considered for this position you should have a BSc/BA/BEng in IT/Automation/Analytics or related field and 5-7 years of experience or equivalent combination of education and experience. Recent experience in a data integrity role is preferred; however, it is not required. 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. 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. 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
The Staff IT Compliance Analyst plays a critical role in ensuring that the Manufacturing IT group operates in full compliance with regulatory requirements, industry standards, and Regeneron's internal quality procedures. This role also oversees the preparation and management of internal and external audits to maintain a state of inspection readiness. As a Staff IT Compliance Analyst, a typical day might include the following: Providing expert guidance and analysis to the Manufacturing IT team on regulatory compliance, quality assurance, and inspection readiness, while managing internal programs to ensure audit preparedness. Evaluating, developing, and refining Manufacturing IT policies, standard operating procedures (SOPs), and practices to align with regulatory requirements, corporate quality standards, and industry best practices. Representing and supporting Manufacturing IT subject matter experts (SMEs) during internal and external audits, while leading the development and execution of responses to audit findings. Establishing, maintaining, and improving metrics to monitor IT compliance, inspection readiness, and audit outcomes, and effectively communicating these findings to stakeholders. Collaborating with global sites to ensure deployed systems comply with business needs, regulatory expectations, and data integrity requirements, while promoting a culture of quality and continuous improvement. Monitoring industry trends in audit observations and regulatory changes, identifying potential compliance gaps, and implementing timely corrective or preventive actions. Supporting IT quality processes, including managing IT deviations, change controls, and the creation or revision of IT quality documents, while demonstrating flexibility and cross-functional expertise. This role may be for you if you have: A deep understanding of GxP regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and expertise in IT system validation and qualification processes. Proven ability to apply quality assurance principles to IT compliance activities, ensuring systems and processes meet both regulatory and corporate quality standards. Strong analytical and problem‑solving skills, with a proactive approach to identifying and resolving compliance risks. Excellent communication and collaboration skills to work effectively across global teams and interact with regulatory inspectors or auditors. In order to be considered for this position, you must hold a BS/BA in Information Technology or related field required along with Principal IT Compliance Analyst: 8 years of relevant experience. Staff IT Compliance Analyst: 10 years of relevant experience. May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Quality Assurance (QA) experience strongly desired. Experience in the pharmaceutical or biotechnology industry preferred. 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. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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
In this role you will be responsible for automation and controls systems project management towards specification, design, start-up, and commissioning in a cGMP environment. As an Associate Automation Engineer, a typical day might include the following: Managing projects related to design, commissioning, and performance improvement of automated equipment Providing design/approval of hardware, software, and controls for automated equipment Providing technical and automation operational support to Manufacturing and Facilities Implementing software/hardware changes and upgrades, understands impact of actions to Manufacturing and Facilities Implementing modification/change control procedures and protocols Supporting the Validation Department with initial design review, software testing, protocol execution and review Programming PLC and HMI application for automated process equipment, capable of troubleshooting and demonstrates knowledge of instrumentation and controls This role may be for you if you: Are a self-starter with high initiative and possess a data-driven approach to problem-solving Have strong interpersonal skills Have demonstrated adaptability and flexibility to working in different environments and teams In order to be considered for this position, you must hold a BS/BEng or higher in Science, Engineering, Instrumentation or Software Programming. May substitute relevant experience for education. 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, 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
We are seeking an Associate Project Engineer who will design, specify and commission new and renovated biopharmaceutical process equipment. This role will provide engineering support and assist with problem solving for existing equipment and manufacturing processes. Typical Day Designing and specifying cGMP process equipment, piping, and/or controls Managing small projects related to process equipment and manufacturing Assisting in the design review, site acceptance and installation of equipment Preparing process and instrument drawings and other related drawings Developing Process Flow Diagrams for manufacturing processes Supporting validation department by preparation of design documents and assists in protocol execution Assisting in investigations of process equipment and control system anomalies Implementing corrective/preventative actions for existing equipment and manufacturing processes Preparing engineering evaluations for and executing modification change control documentation May supervise mechanical, electrical, and automation contractors This role might be for you if you: Are a self-starter with high initiative and possess a data-driven approach to problem-solving Have demonstrated strong interpersonal skills Are able to prioritize, re-prioritize as needed and adapt to change Have strong analytical and organizational skills Have demonstrated adaptability and flexibility to working in different environments, teams etc. To be considered for this position you should have a BEng or higher in Chemical, Process or Mechanical Engineering. We have an inclusive culture that provides comprehensive benefits. 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. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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
The Principal Technical Analyst - Manufacturing Systems will serve as a technical expert responsible for implementing and integrating manufacturing technologies across our biopharmaceutical facilities. You will execute hands‑on technical builds and integrations spanning Nymi biometric systems, IBM Maximo EAMS (Enterprise Asset Management System), and related manufacturing technologies, ensuring compliant deployment that supports operational excellence and predictive maintenance capabilities. Responsibilities Execute technical builds and integrations for manufacturing systems including Nymi biometric authentication, IBM Maximo EAMS, MES platforms, and associated technologies across designated facilities or project portfolios. Implement integration solutions connecting Maximo with predictive maintenance systems, MES workflows, and biometric access controls, following established architectural frameworks. Configure IBM Maximo EAMS modules including work management, asset management, and predictive maintenance capabilities for future release implementations. Build and test Nymi biometric integration points with manufacturing systems to enable secure, compliant user authentication workflows. Execute validation protocols (SDLC Framework aligned to CSA) for manufacturing technology implementations in FDA‑regulated environments, ensuring documentation meets regulatory standards. Implement change control procedures for system modifications, maintaining compliance throughout the development lifecycle. Configure master data elements within assigned systems following established data architecture standards. Support transformation of paper‑based processes into digital workflows while maintaining regulatory compliance requirements. Diagnose integration problems between Maximo, biometric systems, MES platforms, and automation equipment (Ignition, DeltaV, Rockwell). Partner with senior technical leads, automation engineers, and site stakeholders to understand requirements and deliver technical solutions aligned with business objectives. Qualifications Practical experience dealing with project management, particularly dealing with the implementation of new technology and ways of doing things. Ability to understand and engage broader business strategy, work with key department leaders and stakeholders and align activities and initiatives. A demonstrated ability in creation of requirements, design documents and test scripts. Must be competent to work at the technical level of all phases of system design and implementation. Ability to communicate at all levels with clarity and precision both written and verbally together with strong presentation skills. Ability to anticipate client needs and propose alternative business solutions. Knowledge of GMP, 21 CFR Part 11 and Annex 11. Experience & Education BS/BA degree in Information Technology or related field. Principal: 8+ years of progressive industry/relevant experience. Staff: 10+ years of progressive industry/relevant experience. Level is determined based on qualifications relevant to the role. This role may require on‑site work at our biopharmaceutical facilities. Flexibility for site location is essential. 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. Benefits include health and wellness programs (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 (including military and parental leave) for eligible employees at all levels. #J-18808-Ljbffr
Within this role you will oversee a team involved in laboratory quality control testing, and has technical responsibility for all aspects of QC testing. A typical day might include, but is not limited to, the following Coordinating with members of Manufacturing, Stability, and Business Ops to provide analytical support Managing QC Analysts, distributes work load, and monitors progress Managing product testing to ensure efficient and compliant operations Ensuring QC Analysts receive proper training Attending meetings to keep informed of manufacturing priorities Ensuring that safety standards are maintained Ensuring compliance with applicable cGMP regulations and SOPs Investigating a typical and OOS test results as necessary Managing transfers internally from R&D to the QC laboratory or from PAS to the QC Laboratory Managing transfers externally from QC laboratory to contract labs, includes audits if needed Managing QC projects including analytical commitments for Regulatory filing, follow-up actions for general GMP inspections and its readiness Tracking and monitoring the timeline of analytical validation projects Monitoring the team performance for Compliance events, track, assist and organize continuous improvement events Interacting with Regulatory Agencies as needed to ensure cGMP compliance Performing personnel management functions including time sheet submissions, scheduling of vacations, personnel development/feedback, and performance evaluations This role may be for you if you: Contribute to special projects as assigned Demonstrate strong coordination during major analytical investigations Review and approve test reports for accuracy and compliance To be considered for this role, you should have a Bachelors degree (BS/BA) in Chemistry or Biology, along with relevant experience in a pharmaceutical or biotechnology environment, particularly in laboratory management and analytical sciences. Relevant experience may be accepted in lieu of formal qualifications. Education and Experience Manager : Minimum 7+ years of experience Sr Manager: Minimum 8+ years of 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. Equal Opportunity 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. Salary & Employment 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. Background Checks 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
Within this role The Drug Product (DP) Manufacturing Science and Technology (MSAT) Engineer supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities, and will be hands‑on solving issues during technology transfer and cGMP start‑up. The MSAT team establishes best practices for technical support of cGMP drug product manufacturing operations. The Engineer also provides floor support during operations of off‑site manufacturing, reviews process data to ensure operational consistency after the processes are successfully transferred and provides support for investigations. Typical day responsibilities Providing drug product manufacturing process knowledge for new product introduction, technology transfer, process troubleshooting and issue resolution Acting as the technical lead, with the support of cross‑functional teams, for technology transfer of the drug product manufacturing processes to manufacturing facilities Tracking and reporting project milestones related to raw material/component procurement, equipment readiness, analytical process transfer, manufacturing document creation, etc Reviewing and approving cGMP batch documentation (e.g. master batch records, component specifications, validation protocols, material specifications, etc.) required to support cGMP production at manufacturing facilities Assisting with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations Trending process performance and collaborates with internal and external teams to establish/improve process capability to ensure process is operating within intended process control strategy and within cGMP operations Authoring policies, technical reports/protocols, change controls, etc. in support of cGMP activities Supporting development of sampling plans for GMP batches related to lot release, stability and characterization Assisting in equipment selection, qualification and start up activities. Working with manufacturing to ensure robust procedures are utilized for operation of equipment Partnering with Strategic Sourcing/Procurement to specify technical requirements associated with raw materials, components, equipment and services to ensure external vendor on time delivery Maintaining required training status on Regeneron specific work instructions and SOPs To be considered for this role you should have a BS/BA in engineering and 2 years of experience in a pharmaceutical/biologics cGMP environment or equivalent combination of education and experience. Travel to contract manufacturers or business partners, as required, up to 25‑50%. Education and Experience Associate Engineer: Minimum 02 years of experience Engineer: Minimum 2 years of experience 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. 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
Initial Therapeutics, Inc. is looking for a Senior Automation Manager in Ireland to lead the design and implementation of automation systems supporting bioprocessing and manufacturing operations. The ideal candidate will have at least 7 years of experience in the industry, strong team management skills, and knowledge of regulatory compliance. This role includes ensuring operational efficiency and driving continuous improvement in a regulated biotech environment. #J-18808-Ljbffr
We're looking for a Principal Operations Specialist (IT Business Process Automation) to lead workflow automation across ServiceNow and ProcessX, partnering with IAM and QAR stakeholders to streamline processes, strengthen compliance, and improve reliability. You'll own the end-to-end lifecycle from design and integration to operations, incident response, and audit readiness so teams can move faster with confidence. Typical Day Design, build, and maintain automated workflows in ServiceNow and ProcessX to improve operational efficiency and service delivery. Identify, scope, and prioritize automation opportunities across IAM and QAR aligned to business goals and regulatory standards. Optimize platform configurations and integrations for performance, scalability, and compliance, following ITIL and GxP best practices. Monitor and continuously improve service availability, reliability, and throughput against defined SLAs/OLAs; publish clear metrics and dashboards. Define and enforce operational guardrails, SOPs, CSV/validation artifacts, and documentation to ensure GxP, security, and audit readiness. Lead major incident response for automation services; coordinate triage, stakeholder communications, root cause analysis, and post-incident reviews. Create and execute Service Improvement Plans; use data and analytics to measure impact and recommend enhancements. Act as a trusted advisor translate requirements into practical roadmaps and automation solutions; align platform capabilities with stakeholder needs. Partner with Security, QA, and Compliance to meet requirements such as data integrity, access controls, and change governance. Own the automation platform roadmap; evaluate new features, apps, and integrations that extend value across the enterprise. Qualifications Deep hands-on experience with ServiceNow workflow configuration, Flow Designer, IntegrationHub, CMDB, and custom development/integrations. Proven success implementing automation that improves efficiency and compliance in GxP contexts; familiarity with 21 CFR Part 11 and Annex 11. Strong familiarity with IAM and QAR processes in regulated environments and experience operating validated systems using GAMP 5 concepts. Expertise with core ITIL disciplines: Incident, Problem, Change, Request, Monitoring/Reporting; strong operational rigor. Experience creating validation packages and audit-ready documentation; understanding of data integrity controls and operational guardrails. Service management operations at scale, including escalation procedures and on-call/major incident leadership. Technical breadth across operating systems (Windows, Linux), virtualization (VMware), and monitoring/security tools (e.g., Splunk, Claroty, next gen OT tools). ServiceNow certifications (e.g., CSA, CAD, CIS in relevant modules) or equivalent demonstrable expertise. Experience Requirements BS/BA in Information Technology or related field required. Senior: 5 years of experience delivering IT/OT services to business or consumers. Principal: 8 years of experience delivering IT/OT services to business or consumers. May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Strong GxP experience and proven experience in highly regulated environments required. Service Management or support in a large-scale and diverse environment of incident management, escalation procedures and related disciplines. Experience with delivering projects and initiatives in the IT or OT space. Deep experience with ITIL disciplines. Experience with operating systems (Microsoft Windows & Linux), VMware. Experience with monitoring and security tools such as Splunk, Claroty and next gen OT tools. Benefits 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. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401k 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. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's 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
