Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.
Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – 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).
- Conduct capacity planning and performance analyses to inform budgeting, resource allocation, and future investments.
- Evaluate emerging technologies (e.g., IoT, SD-WAN, containerization) for potential implementation in manufacturing and OT contexts.
- Own incident, request, enhancement, knowledge, CMDB, release and change management processes for infrastructure, ensuring compliance with GMP/21 CFR Part 11 and ITIL best practices.
- Oversee patching strategies for both validated and non-validated systems, collaborating with QA/Compliance teams to manage regulated environments.
- Partner with Operational Technology, lab systems, and IoT teams to align manufacturing processes with IT best practices.
- Work 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.
- Implement robust firewall and network segmentation strategies to protect manufacturing networks and lab environments.
- Guide the security posture (SSO, MFA, Zero Trust) in partnership with Information Security teams.
- Continuously evaluate and mitigate infrastructure risks, including vulnerability management and BCP/DR testing.
- Ensure accurate CMDB maintenance and foster knowledge management practices that enhance shift-left efficiency.
- Create advanced dashboards and reports for senior management, highlighting KPIs, trends, and improvement areas.
- Mentor Senior IT Engineers and collaborate with offshore partners to build a high-performing, cross-functional team.
- Encourage continuous learning and skill development, cultivating a culture of innovation and best-practice adoption.
- Ensure 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.
- Lead by example with documentation, compliance, and communication standards, reinforcing knowledge-sharing across the organization.
- Oversee major initiatives to improve reliability, performance, and scalability across on-prem, cloud, and hybrid infrastructures.
- Identify improvement opportunities in processes, automations (e.g., Infrastructure as Code), and advanced monitoring solutions.
- Drive 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
- 5–8+ years of experience in progressive IT infrastructure roles, with 2+ years in a leadership or senior engineering capacity.
- Extensive 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).
- Advanced understanding of database, storage (SAN/NAS), backup/DR solutions, and telephony.
- Proven track record of managing complex security postures, vulnerability remediation, and identity solutions (SSO, MFA).
- Proficiency 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.
- Proficiency 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.
- Strong leadership and mentorship skills, able to motivate and develop high-performing engineering teams.
- Excellent communication and stakeholder management skills, adept at conveying technical details to executive audiences.
- Demonstrated 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.
- Willingness to occasionally travel to other sites or data centers as needed.
- Desire to move into a management role
In return, you’ll be eligible for[1]:
- Day One Benefits
- Medical & Dental Coverage
- Flexible Spending Accounts
- Life and AD&D Insurance
- Supplemental Life Insurance
- Spouse Life Insurance
- Child Life Insurance
- 401(k) Retirement Savings Plan with Company Match
- Time Off Program
- Paid Holidays
- Paid Time Off
- Paid Parental Leave and more
- Adoption Reimbursement Program
- Education Assistance Program
- Employee Assistance Program
- Community and Volunteer Service Program
- Employee Ownership Plan
- Additional Benefits
- Short and Long-Term Disability Insurance
- Voluntary Insurance Benefits
- Vision Coverage
- Accident
- Critical Illness
- Hospital Indemnity Insurance
- Identity Theft Protection
- Legal and more
- Onsite Campus Amenities
- Workout Facility
- Cafeteria
- Credit 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
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