Operation Technology Manager - North America

Inizio Partners; East Windsor Township (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Inizio Partners seeks an Operation Technology Manager in East Windsor, NJ to oversee GMP IT/OT systems across Production, Packaging, Quality, and Supply Chain. You’ll drive digital transformation, ensure serialization compliance, and lead cross-site validation and change control efforts.

The role requires extensive experience with MES/SCADA/DCS, ERP integrations, and a strong track record in data integrity and regulatory inspections. On-site work with 30% travel across MN, WI, and NJ is expected.

Qualifications

• Bachelor's degree in Information Technology, supply chain, Regulatory Affairs, or Manufacturing; advanced degree a plus.
• 10+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems.
• 4 years in a leadership role managing cross-functional programs and teams.
• 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

Responsibilities

• Oversee manufacturing and shop-floor IT systems; ensure uptime, validation, and audit readiness.
• Provide hands-on line support for production equipment and line integration tech.
• Lead end-to-end CSV/validation processes: URS, FS, DS, IQ/OQ/PQ, reviews, and change control.
• Maintain ALCOA+ data integrity; ensure readiness for 21 CFR Part 11 and Annex 11.
• Act as IT-OT executive partner for multiple functions; drive digital roadmaps and cross-functional alignment.
• Lead Pharma 4.0 initiatives: paperless batch records, digital logging, automated reporting, IoT and AI on the floor.
• Oversee IT-OT serialization programs and vendor/contract management.
• Build resilient 24/7 on-call coverage; drive post-incident reviews and continuous improvement.

Skills

Manufacturing IT/OT leadership

GxP compliance

CSV / validation

Data integrity

Serialization

Cross-functional leadership

Regulatory inspections

Education

Bachelor's degree in IT or Engineering

Tools

MES

SCADA/DCS

Tracelink

Optel

Systech

Antares

ERP (SAP)

LIMS

QMS

Job description

Reports to: Head, Product Services, Operations and Compliance

Location: East Windsor, NJ

About the Role

The Operation Technology 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 will be responsible for IT/OT systems across all manufacturing sites across Minnesota, Wisconsin, and New Jersey.

Responsibilities

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.
• 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.

3. GMP Compliance, CSV & Data Integrity

• Set and sustain the standard for GMP, cGMP, and GAMP 5 compliance across all manufacturing and lab systems - this is a non-negotiable foundation, not a checkbox.
• Lead Computer System Validation (CSV) end-to-end: URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control - building capability in the team to reduce cycle time without compromising quality.
• Uphold ALCOA+ principles for data integrity and electronic records; maintain readiness for 21 CFR Part 11, Annex 11, and applicable QC/QA processes across all sites.
• Act as a trusted voice in Quality forums - capable of explaining technical risk in plain language and proposing pragmatic, compliant solutions.

4. Cross-Functional Leadership & Stakeholder Partnership

• Operate as the primary IT-OT executive partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply Chain - building relationships grounded in trust, transparency, and delivery.
• Lead business engagement forums, prioritization councils, and change control boards - facilitating alignment across functions with competing priorities and timelines.
• Translate operational pain points into digital roadmaps and executable programs of work; communicate progress, risks, and decisions in a way that resonates with both plant-floor supervisors and the C-suite.
• Proactively surface cross-functional dependencies, resolve conflicts early, and ensure no critical initiative stalls because stakeholders aren't aligned.
• Represent IT in regulatory inspections, customer audits, and internal quality reviews - with the confidence and credibility to speak to systems, processes, and controls under scrutiny.
• Drive Pharma 4.0 initiatives: paperless batch records, digital logbooks, automated reporting, IoT sensors, machine connectivity, and AI-based intelligence on the shop floor.
• Lead system upgrades, migrations, and integrations for manufacturing and packaging platforms
• Vendor & Contract Management - manage vendor relationships, contracts, SLAs, and performance reviews.
• Identify and champion continuous improvement opportunities - build a culture where the team doesn't just support the status quo but actively makes it better.
• Benchmark against pharma industry best practices and bring external perspective and innovative thinking into manufacturing IT/OT strategy.

6. OT Infrastructure & Cybersecurity

• Oversee plant networks, servers, manufacturing VLANs, and segregated OT environments - in close partnership with the corporate Network and Security teams.
• Ensure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructure - own OT/IT segmentation and patch governance for the manufacturing environment.
• Align with corporate IT on patching cadence, backups, disaster recovery, and user access governance - acting as the bridge between OT realities and corporate security policy.

7. Operational Support & Incident Management

• Provide real-time, decisive support during batch execution failures, packaging line downtime, serialization events, and lab workflow disruptions - the team looks to you to set the tone under pressure.
• Build and maintain a structured 24/7 on-call rotation model to ensure coverage across all sites; ensure escalation paths are clear, response SLAs are met, and every incident drives a learning.
• Establish post-incident review discipline - RCA, corrective action, and closure - so the same issue never brings a line down twice.

8. Team Leadership & Organizational Development

• Lead, inspire, and develop a team of shop-floor /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.
• Set high standards and hold the team to them -create an environment where people feel safe raising issues early, taking calculated risks, and are continuously learning.
• Foster a culture of compliance, urgency, and continuous improvement; model the behaviors you want to see and recognize them when you see them in others.
• Build, lead, and sustain a high-performing manufacturing IT organization by recruiting and retaining top talent, securing the resources needed to achieve strategic objectives, and driving succession planning, talent development, and capability building to support long-term organizational growth and continuity.
• Demonstrates strong operational and technical leadership, applying a disciplined, data-driven approach to problem-solving, investigations, compliance activities, and business priorities.
• Builds credibility and trust through proactive communication, ensuring stakeholders are informed, aligned, and confident in project progress, risks, and outcomes.
• Leads teams with a strong sense of accountability and ownership, fostering a culture that anticipates issues, drives timely resolution, and continuously improves performance.
• Maintains a high level of compliance and operational readiness by ensuring systems, documentation, processes, and team practices consistently meet regulatory and business requirements.
• Identifies opportunities to improve processes, systems, and ways of working, leveraging technology and automation to increase efficiency, reliability, and business value.
• Develops and coaches team members, creating an environment that supports engagement, capability building, knowledge sharing, and career growth.
• Effectively prioritizes competing demands and resources, balancing day-to-day operational needs with strategic initiatives and organizational objectives.
• Collaborates cross-functionally to align IT solutions with manufacturing, quality, engineering, and business goals, driving successful outcomes through partnership and influence.

Qualifications/Requirements

• Bachelor's degree in Information Technology, supply chain, , Regulatory Affairs, or Manufacturing,, Engineering, advanced degree a plus.
• 10+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems
• 4 years in a leadership role managing cross-functional programs and teams
• 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