Senior Manufacturing Systems Specialist

Job Description

At ANI Pharmaceuticals, we are dedicated to improving patients' lives through the development, manufacturing, and distribution of high-quality pharmaceutical products. Our diverse portfolio of generic and branded pharmaceuticals makes us a trusted partner for healthcare providers, pharmacists, and patients worldwide. We are committed to ensuring broad access to essential therapies across multiple therapeutic areas. At ANI, every employee has the opportunity to contribute to our purpose.

We value authenticity, expertise, and hard work, and we foster a collaborative environment where individuals can thrive, grow, and make a meaningful impact.

The Senior Manufacturing Systems Specialist is responsible for the design, implementation, maintenance, and optimization of manufacturing automation and operational technology (OT) systems. This role partners closely with Manufacturing, Operations, Quality, Engineering, and IT teams to ensure reliable system performance, support process improvements, and drive automation initiatives across manufacturing sites.

The ideal candidate will possess strong technical expertise in manufacturing automation, industrial control systems, and network infrastructure, along with experience operating within a regulated pharmaceutical manufacturing environment.

Manufacturing Automation & Systems Management

• Manage the performance, reliability, and lifecycle of manufacturing automation systems.
• Monitor and support manufacturing software applications and automation infrastructure.
• Lead system upgrades, patches, enhancements, and configuration changes.
• Collaborate with vendors and internal stakeholders to resolve technical issues and implement improvements.

Process Improvement & Operational Excellence

• Identify opportunities to improve automation functionality, system performance, and operational efficiency.
• Support continuous improvement initiatives through automation and technology enhancements.
• Ensure the integrity, accuracy, and availability of system data used in operational decision-making and reporting.

Project Leadership

• Lead automation-related projects, including new system implementations, integrations, upgrades, and process automation initiatives.
• Support project planning, road-mapping, testing, deployment, and post-implementation activities.
• Coordinate project activities with cross-functional teams and external partners.

User Support & Training

• Provide technical support and troubleshooting for manufacturing systems and automation platforms.
• Develop and deliver user training to ensure effective system utilization and adoption.
• Serve as a subject matter expert for manufacturing automation technologies.

Compliance, Security & Infrastructure

• Maintain compliance with applicable regulatory requirements, company standards, and data integrity principles.
• Support cybersecurity initiatives related to manufacturing systems and operational technology environments.
• Assist in troubleshooting plant infrastructure, manufacturing software, and automation-related systems.

Required Qualifications

• Bachelor's degree in Information Technology, Computer Science, Engineering, or a related discipline.
• 5-7+ years of experience supporting manufacturing automation systems in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Hands-on experience implementing, upgrading, and maintaining automation systems.
• Knowledge of regulatory compliance requirements and industry standards applicable to pharmaceutical manufacturing.
• Ability to travel up to 30% between manufacturing sites.

Preferred Qualifications

• Strong understanding of manufacturing automation platforms and network protocols, including TCP/IP, DNS, and DHCP.
• Experience with network infrastructure components such as routers, switches, firewalls, and cybersecurity technologies.
• Familiarity with Operational Technology (OT), Industrial Control Systems (ICS), and related frameworks such as NIST and ISA-99.
• Proven analytical, troubleshooting, and problem-solving skills.
• Strong communication, stakeholder management, and project leadership capabilities.

The base salary range for this position is $110,000 - $125,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition, ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.