Manufacturing IT & Digital Operations Lead (Hybrid)

ANI Pharmaceuticals, Inc.; Princeton (NJ); Hybrid; USD 150,000 - 175,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Disability insurance

Retirement plan

Paid leave

Paid holidays

PTO

Job summary

ANI Pharmaceuticals, Inc. in Princeton, NJ (Hybrid) seeks a Senior Manager, Manufacturing IT Manager & Digital Operations to lead shop-floor IT systems across GMP environments and drive digital transformation.

The role requires deep serialization and cross‑functional leadership to ensure compliance and seamless data flows. The candidate will own end‑to‑end validation, serialization programs, and OT security while partnering with Quality and Supply Chain to sustain audit readiness and continuous

Qualifications

• Bachelor’s degree in IT, supply chain, regulatory affairs or manufacturing engineering required.
• 10+ years in pharmaceutical serialization or EPCIS-based systems.
• 4+ years in a leadership role managing cross-functional programs.
• Deep expertise across MES, ERP, LIMS, QMS, SCADA/DCS and serialization.

Responsibilities

• Oversee manufacturing IT systems across GMP environments and multiple sites.
• Lead end‑to‑end CSV validation, URS, FS, IQ/OQ/PQ, and change control.
• Ensure data integrity (ALCOA+) and audit readiness across manufacturing and labs.
• Partner with Quality, Regulatory, and Supply Chain to meet serialization compliance.
• Drive Pharma 4.0 initiatives: paperless batch records, IoT, and automated reporting.

Skills

Leadership

Serialization

MES/ERP integration

Regulatory compliance

Data integrity

Education

Bachelor’s degree in Information Technology, Supply Chain, Regulatory Affairs, or Manufacturing Engineering

Advanced degree a plus

Tools

SAP

Tracelink

EPCIS

LIMS

Job description

ANI Pharmaceuticals, Inc. in Princeton, NJ (Hybrid) seeks a Senior Manager, Manufacturing IT Manager & Digital Operations to lead shop-floor IT systems across GMP environments and drive digital transformation.

The role requires deep serialization and cross‑functional leadership to ensure compliance and seamless data flows. The candidate will own end‑to‑end validation, serialization programs, and OT security while partnering with Quality and Supply Chain to sustain audit readiness and continuous