Pharma IT/OT Leader - NA Manufacturing & Serialization

Inizio Partners Corp

East Windsor Township (NJ)

On-site

USD 130,000 - 170,000

Full time

14 days+

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Job summary

Inizio Partners Corp seeks an Operation Technology Manager to oversee GMP-regulated manufacturing IT/OT systems across multiple sites in the NA region, including East Windsor, NJ. The role focuses on uptime, compliance, and integration across production, packaging, QA, and supply chain.

You will lead serialization programs, drive digital transformation, and ensure data integrity and regulatory readiness, partnering with Quality and Regulatory teams to sustain audit readiness and continuous

Qualifications

Bachelor's degree in IT, supply chain, regulatory affairs, or manufacturing engineering.
10+ years in pharmaceutical serialization or EPCIS-based systems preferred.
Experience leading cross-functional programs and teams.
Deep GMP/compliance credentials: CSV (GAMP 5, 21 CFR Part 11, Annex 11).
Travel up to 30% between MN, WI, NJ sites.

Responsibilities

Oversee manufacturing IT/OT systems (MES, ERP integrations, LIMS, QMS, SCADA/DCS) and ensure validation and uptime.
Lead end-to-end serialization programs and regulatory submissions across packaging lines.
Manage CSV lifecycle: URS, FS, DS, IQ/OQ/PQ, change control.
Maintain ALCOA+ data integrity and 21 CFR Part 11 readiness.
Partner with Quality, Supply Chain, and Regulatory to ensure audit readiness.
Drive Pharma 4.0 initiatives: paperless batch records, digital logs, automated reporting.
Lead a North America IT/OT team; build capability roadmaps and succession plans.