IT Technical Program Manager (Java/Pharma Domain)

Cloud Analytics Technologies, LLC; New Jersey; On-site; USD 96,000 - 152,000; Full time

Job summary

CLOUD ANALYTICS TECHNOLOGIES LLC is seeking an IT Technical Program Manager to lead complex pharma IT initiatives in New Jersey. You will drive programs spanning MES, LIMS, SAP, and scheduling systems, ensuring GxP compliance and CSV readiness for FDA-regulated environments.

The role requires deep experience in US pharma manufacturing, strong cross‑functional leadership, and the ability to manage vendor relationships and regulatory audits while delivering on schedule and budget.

Qualifications

• 15+ years IT experience with 7+ years in technical program management in pharma.
• Deep understanding of US pharma manufacturing and regulatory requirements.
• Proven ability to lead cross-functional teams across IT, QA, and manufacturing.
• Experience with vendor management and regulatory readiness activities.
• Familiar with CSV and 21 CFR Part 11 compliance in digital systems.

Responsibilities

• Lead IT programs spanning MES, LIMS, SAP, and scheduling systems.
• Drive validation strategies and CSV planning across complex platforms.
• Ensure GxP compliance and inspection readiness for FDA-regulated environments.
• Coordinate with Digital, Engineering, Quality, Regulatory, and Manufacturing teams.
• Manage vendors and oversee milestones, risks, and timelines.

Skills

PM leadership

Pharma domain expertise

GxP compliance

CSV (Computer System Validation)

Vendor management

Regulatory audits

Cross-functional collaboration

System integration

SAP familiarity

Tools

MES

LIMS

SAP

Scheduler

Control systems

mINT Engine

Job description

IT Technical Program Manager (Java/Pharma Domain)

Location:

New Jersey, NJ

Duration:

12Months+ Extension

Hourly Rate:

Depending on Experience (DOE)

Work Authorization:

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
• 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).
• 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:

CLOUD ANALYTICS TECHNOLOGIES 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. CLOUD ANALYTICS TECHNOLOGIES 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 CLOUD ANALYTICS TECHNOLOGIES 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

Equal Opportunity Employer

CLOUD ANALYTICS 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. CLOUD ANALYTICS 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 CLOUD ANALYTICS 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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