Plant Operations Technology Manager (Pharma)
Inizio Partners - East Windsor, NJ
Hiring: Plant Operations Technology Manager (Pharma) Company: Inizio Partners Location: East Windsor, NJ Job Posted Time: 2026-09-16 16:39:09 Employment Type: Contract Target Skills & Keywords : Digital Transformation, Manufacturing Execution Systems, SAP, SCADA, Vendor Management About the job Experience: •10+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems •4 years in a leadership role managing cross-functional programs and teams Required Skills: •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. •Drive real-time troubleshooting on the production floor; build escalation frameworks that get issues resolved fast and root causes documented properly. •Serve as the accountable IT-OT owner for all manufacturing system change control, vendor management, and lifecycle planning. •Lead OT oversight for end-to-end serialization across all packaging lines — from equipment configuration through regulatory submission. •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 at all times. •Proactively identify serialization risks; communicate them clearly to leadership and mobilize cross-functional response before they become audit findings. Qualifications: •Direct message the job poster from Inizio Partners •Precision hiring for exceptional organizations. •Head, Product Services, Operations and Compliance •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, serialization platforms (Tracelink, Optel,, and 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. •Travel: up to 30% between sites in MN, WI and NJ Compensation: •$165,000 - $185,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!