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Sr. IT/OT Support Engineer, GxP Manufacturing and Labs

$130.8k - $209.4k

BioSpace

Sr. IT/OT Support Engineer, GxP Manufacturing and Labs Join to apply for the Sr. IT/OT Support Engineer, GxP Manufacturing and Labs role at BioSpace The Role We are seeking a skilled and customer-focused GxP IT Engineer to provide hands‑on technical support for endpoints, laboratory instruments, and connected devices operating in Moderna’s regulated (GxP) environments. This role is essential to ensuring the reliability, compliance, and security of IT systems that underpin critical manufacturing and laboratory operations. Here’s What You’ll Do Provide hands‑on technical support for endpoints, laboratory instruments, and connected devices in GxP‑regulated manufacturing and lab environments, ensuring reliable, compliant, and secure operations. Support and maintain key systems including MES (Syncade), DeltaV, OSI PI, BMS, ThinManager, and Zebra label printers, ensuring uptime, proper configuration, and integration with related systems. Partner with automation, lab, and manufacturing teams to ensure systems and instruments are properly installed, qualified, and supported through their lifecycle — from deployment to decommissioning. Collaborate with Digital Core, Cybersecurity, and Quality teams to ensure all systems meet Moderna’s IT and compliance standards, including patching, access management, and vulnerability remediation. Perform troubleshooting, maintenance, and configuration activities on GxP endpoints and instrument‑connected PCs, ensuring alignment with established SOPs, ITSM processes, and change control requirements. Participate in incident, problem, and service request management activities, maintaining clear documentation, root cause analysis, and audit‑ready records. Ensure GxP systems and endpoints are managed according to approved lifecycle processes, including system validation (IQ/OQ/PQ), periodic review, and decommissioning. Collaborate with vendors and internal stakeholders to resolve complex technical issues and drive continuous improvement in reliability and service delivery. Contribute to the development of standard operating procedures, work instructions, and technical documentation to promote consistency and compliance across global sites. Participate in cross‑functional initiatives to strengthen GxP IT service management, helping to embed security, compliance, and operational excellence into daily support practices. Here’s What You’ll Need (Basic Qualifications) Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field—or equivalent relevant experience. 7+ years of hands‑on experience supporting GxP IT systems, laboratory instruments, or manufacturing technology in a pharmaceutical or biotech environment. Strong understanding of GxP principles, computerized system validation (IQ/OQ/PQ), and documentation practices required in regulated settings. Experience supporting or integrating systems such as MES (Syncade), DeltaV, OSI PI, BMS, LIMS, and ThinManager, along with laboratory instruments and Zebra printers. Proven ability to troubleshoot and support Windows endpoints and instrument‑connected PCs, ensuring compliance with corporate security standards. Familiarity with Cybersecurity controls and endpoint protection tools (e.g., CrowdStrike or equivalent). Experience collaborating with cross‑functional teams, including automation, lab engineering, Quality, and Cybersecurity, to deliver reliable and compliant system operations. Working knowledge of IT Service Management (ITSM) concepts (incident, change, and problem management) and experience in SOP‑driven, audit‑ready environments. Excellent communication, documentation, and stakeholder engagement skills, with a focus on consistency, accountability, and service excellence. Understanding of network routing, switching and firewall concepts. Here’s What You’ll Bring to the Table (Preferred Qualifications) Strong analytical and problem‑solving skills with a proactive, solution‑oriented mindset. Demonstrated ability to remain calm and effective under pressure while supporting critical manufacturing and laboratory operations in a 24x7 environment. Excellent communication and interpersonal skills, with the ability to collaborate across IT, Automation, Engineering, Manufacturing, Quality, and Cybersecurity teams. Highly organized, detail‑oriented, and disciplined in following established processes documentation standards, and compliance requirements. Proven ability to work independently and manage priorities with minimal supervision while maintaining alignment with team goals and service expectations. Adaptable and resourceful—able to navigate change in a dynamic, high‑growth, and compliance‑driven environment. Strong sense of ownership, accountability, and commitment to delivering high‑quality, reliable, and compliant technical support. Collaborative mindset with a focus on partnership, transparency, and continuous improvement within a global, cross‑functional team. Pay & Benefits Best‑in‑class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well‑being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown Savings and investment opportunities to help you plan for the future Location‑specific perks and extras The salary range for this role is $130,800.00 - $209,400.00. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world‑class team. Our Working Model As we build our company, we have always believed an in‑person culture is critical to our success. Moderna champions the significant benefits of in‑office collaboration by embracing a 70/30 work model. Equal Opportunities Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Accommodations Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. #J-18808-Ljbffr BioSpace

Vacancy posted 1 day ago
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