GxP Systems Engineer

Rockville, MD
Jan 27, 2023
Feb 02, 2023
Full Time
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.Your Role:At MilliporeSigma, as the GxP Systems Engineer, you will perform a variety of tasks within the Quality Assurance department including configuration and administration of laboratory systems and associated software. You will participate in and/or lead project teams across global operational departments to implement new laboratory systems.Perform administration tasks for a variety of GxP systems and associated software in a regulated (GxP) environment following defined procedures. Defining, assigning, and managing user access across Contract Testing Services (CTS)LeadSoftware/System Development Lifecycle (SDLC) activities and manage Operational Technology (OT) deliverables (including but not limited to System Inventory management, Risk Assessment, Infrastructure Management, Data Classification and Protection, Data Privacy assessments and Service Level Agreements)Own, manage and maintain GxP system lifecycle activities (including but not limited to Change management, SOP management, Events/CAPAs, Disaster Recovery and Business Continuity processes, Data Integrity assessments and implementing controls)Act as liaison with wider business and collaborate between CTS departments on all SDLC activities (including but not limited to Validation, Change Management, Periodic Review, Decommissioning) for GxP computerized systems. Ensures transition of OT Systems from project to operationsResponsible for troubleshooting, incident management, servicing, maintenance, or other support functions for software or firmware associated with laboratory systems including OS upgrades, patch management, Infrastructure management and system securityAct as liaison and interface between laboratory users, IT, OT, Engineering, Validation and external vendors in selection, implementation, and lifecycle management of laboratory systems. Responsible for maintenance plan and contracts with vendorsResponsible for timely communication of status of user requests and/or system outage reporting (eg, helpdesk tickets)Who You Are:Minimum Qualifications:Bachelor's Degree in a scientific field (eg, Biology, Chemistry, etc.) or technical field (eg, Computer Science, Software Engineering, etc.)2+ years in a technical role supporting/administrating software applications or laboratory systemsPreferred Qualifications:Understanding of GxP regulations and guidelines including but not limited to GAMP 5, US Code of Federal Regs. 21 CFR Part 11 and Part 211, Eudralex Volume 4, Annex 11 & Annex 15, ICH Q7, Q8, Q9 & Q10Acts ethically and ensures quality of own work and that of othersWorks with agility and willing to embrace and implement change on a global scaleApplies technology to drive digitalization, improve quality and increase customer valueExcellent communication and facilitation skills (ability to lead cross-functional meetings, demonstrated ability to bring consensus among diverse cross-functional teams)Proficient knowledge and application of FDA and EU regulations (cGMP, GLP)Advanced knowledge and application of data integrity regulatory guidance (eg, FDA, MHRA, WHO)Understand quality standards for GxP software applications and systemsWhat we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!Apply now and become a part of our diverse team!If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.htmlJob Requisition ID: 260297 Location: Rockville Career Level: C - Professional (1-3 years) Working time model: full-time North America DisclosureThe Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.Notice on Fraudulent Job OffersUnfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.Job Segment: Testing, Laboratory, Computer Science, QA, Quality Assurance, Technology, Science, Quality