IT Technical Program Manager (Java/Pharma Domain)

MACHINE LEARNING TECHNOLOGIES LLC; Trenton (NJ); On-site; USD 83,000 - 152,000; Full time

Job summary

Machine Learning Technologies LLC in New Jersey is seeking an IT Technical Program Manager (Java/Pharma Domain) to lead cross‑functional IT programs within regulated manufacturing environments.

You will oversee integrations with MES, LIMS, SAP, and scheduling systems, ensure GxP compliance, and drive validation activities (CSV) across complex digital platforms. This role requires deep pharma domain expertise and strong collaboration with QA, Regulatory, and manufacturing teams.

Qualifications

• Extensive experience in IT program management within pharma or regulated industries.
• Strong knowledge of validation and GxP compliance.
• Experience with MES/LIMS/SAP integrations is a plus.

Responsibilities

• Lead IT programs spanning MES, LIMS, SAP, and scheduling systems.
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Develop validation strategy and execute CSV planning across complex digital systems.
• Ensure platforms are inspection-ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Drive cross-functional alignment and vendor management for complex projects.

Skills

React JS

Python

Java

Camunda BPM

Tools

RESTful APIs

Webmethods

Job description

Job Description

Job Overview

• Job ID: J52578
• Job Title: IT Technical Program Manager (Java/Pharma Domain)
• Location: New Jersey, NJ
• Duration: 12 Months + Extension
• Hourly Rate: Depending on Experience (DOE)
• Work Authorization: US Citizen, Green Card, OPT-EAD, CPT, H-1B, H4-EAD, L2-EAD, GC-EAD
• Client: To Be Discussed Later
• Employment Type: W-2, 1099, C2C

Role Overview

Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing, orchestration, integration, and compliance within regulated pharmaceutical environments—spanning vendor systems such as MES, LIMS, SAP, and scheduling systems.

Key Responsibilities

• Overall 15-17+ years of IT experience and 7+ year of experience in technical program management with deep experience in US pharma, Drug Manufacturing, Cell Therapy and US pharma regulations.
• Cross‑Functional Program Leadership
• Manage end-to-end IT programs (e.g., MES/LIMS/SAP integrations, scheduler systems, orchestration platforms).
• Coordinate with Digital, Engineering, Quality, Regulatory, QA, and Manufacturing teams.
• Strong knowledge of GxP regulations, validation lifecycle, and digital manufacturing system landscapes.
• Experience with MES, LIMS, SAP, Scheduler, Control systems, integration architectures.
• Experience in personalized or cell therapy manufacturing environments.
• Familiarity with digital validation frameworks in CAR‑T and related cell therapy platforms.
• Computer System Validation (CSV)
• Develop validation strategy and execute CSV planning across complex digital systems.
• Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
• Regulatory Readiness & Inspection Support
• Ensure platforms are inspection‑ready for BLA submissions and manufacturing transitions.
• Represent Digital in regulatory audits and inspections.
• Technical and Architectural Oversight
• Engage in technical design/architecture discussions to de‑risk validation.
• Ensure integration readiness across systems (e.g., mINT Engine, Scheduler, Control Tower).
• Validation Deliverables Management
• Develop/maintain CSV artifacts: plans, risk assessments, URS, protocols, test scripts, trace matrices, validation reports
• Business Engagement & Leadership
• Able to drive cross‑functional alignment and clear communication across scientific, operational, IT, and QA/regulatory teams.
• Capable of managing vendors, delivering on complex project scopes, milestones, timelines.

Required Technical Expertise

• Programming & Frameworks: React JS, Python, Java, Camunda BPM.
• Data & Analytics: SQL, Python, R; Snowflake, Azure Synapse, Databricks;
• Cloud Ecosystems: AWS,
• Integration: RESTful APIs, Webmethods.

Equal Opportunity Employer

MACHINE LEARNING TECHNOLOGIES LLC is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. MACHINE LEARNING TECHNOLOGIES LLC will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will MACHINE LEARNING TECHNOLOGIES LLC require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract.

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