which are all directly injected into patients worldwide.

As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards. While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. Why join Team Simtra?

Because we:

Make it HAPPEN

We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it

TOGETHER

We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways. Make it RIGHT
We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members. Make it COUNT
We take pride in our day-to-day work, knowing the impact we make
taking on challenges big and small to improve patient health.

The role:

The Lead IT Engineer provides strategic oversight and technical leadership across all facets of the organization's infrastructure-servers, cloud, networking, storage, telephony, and endpoint management-ensuring security and reliability. They will work with both non-validated and validated systems to ensure compliance under

GMP/21 CFR

Part 11. Acting as the highest-level escalation point, you will architect solutions, define roadmaps, and guide large-scale projects that shape the future of IT operations. This includes working with operational technology, lab systems, and strategic partners to align IT best practices with evolving business requirements. You will lead continuous service improvements, oversee release and change management in ServiceNow, and support a culture of innovation and knowledge-sharing. Success in this role includes exceptional technical leadership, strategic thinking, and stakeholder management to deliver robust, secure, and scalable infrastructure solutions for the enterprise. Further, this is a pre-management role, with the expectation that the incumbent develop and refine the skills needed to providing leadership, oversight and management of all plant information technology solutions and teams. This is an onsite role in Bloomington, IN.

The responsibilities:

Act as the final/highest-level escalation point and the point of contact for external vendor escalations for infrastructure support tickets and complex issues, including network outages, major incidents, or system failures. Use ServiceNow to manage incidents, service requests, and changes adhering to established SLAs and ITSM processes and providing professional and quality service. Participate and run the Major Incident Management process and coordinate efforts for resolution. Collaborate on long-term architecture and technology roadmaps for on-prem and cloud environments (Azure, AWS).\nConduct capacity planning and performance analyses to inform budgeting, resource allocation, and future investments.\nEvaluate emerging technologies (e.g., IoT, SD-WAN, containerization) for potential implementation in manufacturing and OT contexts.\nOwn incident, request, enhancement, knowledge, CMDB, release and change management processes for infrastructure, ensuring compliance with

GMP/21 CFR

Part 11 and ITIL best practices.\nOversee patching strategies for both validated and non-validated systems, collaborating with QA/Compliance teams to manage regulated environments.\nPartner with Operational Technology, lab systems, and IoT teams to align manufacturing processes with IT best practices.\nWork with IT Business Analysts, Senior Engineers, and offshore support teams to deliver integrated solutions for critical applications. Maintain and improve collaboration and communication systems. Including cisco telephony for IP and non-IP phone systems, conference rooms, Microsoft teams, multi-function printers and secure print. Liaise with vendors, consultants, and third-party providers for specialized projects or advanced troubleshooting.\nImplement robust firewall and network segmentation strategies to protect manufacturing networks and lab environments.\nGuide the security posture (SSO, MFA, Zero Trust) in partnership with Information Security teams.\nContinuously evaluate and mitigate infrastructure risks, including vulnerability management and BCP/DR testing.\nEnsure accurate CMDB maintenance and foster knowledge management practices that enhance shift-left efficiency.\nCreate advanced dashboards and reports for senior management, highlighting KPIs, trends, and improvement areas.\nMentor Senior IT Engineers and collaborate with offshore partners to build a high-performing, cross-functional team.\nEncourage continuous learning and skill development, cultivating a culture of innovation and best-practice adoption.\nEnsure all Infrastructure and Operations efforts are completed on-time and with quality which includes managing and enhancing monitoring and alerting, backup and recovery, patching, and performing analysis to build reliable, resilient, secure, and scalable systems.\nLead by example with documentation, compliance, and communication standards, reinforcing knowledge-sharing across the organization.\nOversee major initiatives to improve reliability, performance, and scalability across on-prem, cloud, and hybrid infrastructures.\nIdentify improvement opportunities in processes, automations (e.g., Infrastructure as Code), and advanced monitoring solutions.\nDrive collaboration between corporate IT, OT, lab systems, and offshore partners for seamless end-to-end service delivery.

Required qualifications:

Education & Experience:

Bachelor's or master's degree in computer science, IT, or related field; or equivalent experience\n5-8+ years of experience in progressive IT infrastructure roles, with 2+ years in a leadership or senior engineering capacity.\nExtensive experience in regulated (GMP/21 CFR Part 11) environments, overseeing validated and non-validated systems preferred.

Technical Skills:

Expert-level knowledge of server/virtualization (Windows, Linux, VMware/Hyper-V), networking (firewalls, LAN/WAN, SD-WAN), and cloud architectures (Azure, AWS).\nAdvanced understanding of database, storage (SAN/NAS), backup/DR solutions, and telephony.\nProven track record of managing complex security postures, vulnerability remediation, and identity solutions (SSO, MFA).\nProficiency in ServiceNow or similar ITSM platforms, leveraging advanced features (dashboards, automation, CMDB). Strong knowledge and understanding of Operational Technology setups, lab systems, and compliance requirements in a manufacturing context.\nProficiency in the following technical stacks

Cisco (wireless, switching), Fortinet (firewalls/SDWAN), Ubiquiti (wireless, switching), Windows Server, Hyper-V/SCVMM, VMware, MS SQL, Azure IaaS/PaaS, M365, and Veeam.

Soft Skills:

Exceptional strategic thinking and architecture design capabilities.\nStrong leadership and mentorship skills, able to motivate and develop high-performing engineering teams.\nExcellent communication and stakeholder management skills, adept at conveying technical details to executive audiences.\nDemonstrated ability to handle major incidents and make critical decisions under pressure. A self-starter who remains current with industry trends, tools, and best practices. Additional Requirements Availability to participate in 24/7 on-call rotation. Ability to work on-site in a regulated pharmaceutical/manufacturing setting, adhering to all compliance and safety standards.\nWillingness to occasionally travel to other sites or data centers as needed.\nDesire to move into a management role In return, you'll be eligible for[1]: Day One Benefits Medical & Dental Coverage\nFlexible Spending Accounts\nLife and AD&D Insurance\nSupplemental Life Insurance Spouse Life Insurance\nChild Life Insurance 401(k) Retirement Savings Plan with Company Match\nTime Off Program Paid Holidays\nPaid Time Off\nPaid Parental Leave and more Adoption Reimbursement Program\nEducation Assistance Program\nEmployee Assistance Program\nCommunity and Volunteer Service Program\nEmployee Ownership Plan Additional Benefits Short and Long-Term Disability Insurance Voluntary Insurance Benefits Vision Coverage\nAccident\nCritical Illness\nHospital Indemnity Insurance\nIdentity Theft Protection\nLegal and more Onsite Campus Amenities Workout Facility\nCafeteria\nCredit Union [1] Current benefit offerings are in effect through 12/31/26 Disclaimer This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements. Equal Employment Opportunity Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Data Privacy To learn more about Simtra's approach to data privacy, please review the

Simtra Recruitment Platform Global Privacy Policy:

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