Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients’ lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike, offering accessible products across a wide range of therapeutic areas to support communities globally. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, and our culture empowers every employee to succeed and apply their full potential in a positive environment.
The Manufacturing IT Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements. This role spans all ANI Pharmaceuticals manufacturing sites across Minnesota, Wisconsin, and New Jersey.
1. Manufacturing Systems & Shop-Floor Technology
Own and evolve a portfolio of critical manufacturing systems, MES, ERP integrations, LIMS, QMS, data historians, SCADA/DCS, ensuring they are stable, validated, and business-enabling.
Provide hands-on line support for production and packaging equipment: HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology.
2. Serialization & Track-and-Trace
Manage Level 2–4 serialization systems (Antares, Systech, Tracelink, Optel) and ensure seamless integration with ERP, Quality, and regulatory data flows.
Own DSCSA, EU FMD, and global serialization compliance, partnering closely with Quality and Supply Chain to maintain audit readiness and full traceability.
3. GMP Compliance, CSV & Data Integrity
Lead Computer System Validation (CSV) end-to-end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control, reducing cycle time without compromising quality.
8. Team Leadership & Organizational Development
Lead, inspire, and develop a team of shopfloor/OT analysts, automation support engineers, and system administrators across the North America region.
Build individual capability roadmaps for team members, investing in GMP systems knowledge, shop-floor automation, integration expertise, and CSV skills.
Qualifications / Requirements
Bachelor’s degree in Information Technology, Supply Chain, Regulatory Affairs, or Manufacturing Engineering; advanced degree a plus.
Deep expertise across MES, ERP (SAP preferred), LIMS, QMS, SCADA/DCS, and serialization platforms with shop-floor integration technologies.
Proven GMP compliance credentials: hands-on CSV experience (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+) and a track record of sustaining compliance across multiple sites and audits.
The base salary (hourly) range for this position is $150,000–$175,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. Only to be included if position is STI and/or LTI bonus eligible: In addition to base salary, this position is eligible for participation in a competitive short-term (and long-term) incentive program based on performance and company results.
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.
