Technical Program Manager

Edison, NJ - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Position: IT Technical Program Manager (Pharma Domain)

Location: New Jersey (Day1 onsite)

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 12-17 years of IT experience and 7year 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.

Thanks & Regards

Ahmed Ali

IT Recruiter

Momento USA Exceeding Customer Expectations

440 Benigno Blvd Unit#A-5 2nd Floor Interstate Business Park Bellmawr NJ 08031

Phone No: Ext: 1026 Fax: Email: Ahmed@ Web:

Linkedin : Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex pregnancy sexual orientation gender identity national origin age protected veteran status or disability status.

Position: IT Technical Program Manager (Pharma Domain) Location: New Jersey (Day1 onsite) Role Overview: Lead and oversee IT initiatives supporting cell therapy digital platforms that drive manufacturing orchestration integration and compliance within regulated pharmaceutical environments-spannin...

Position: IT Technical Program Manager (Pharma Domain)

Location: New Jersey (Day1 onsite)

Key Responsibilities:

Overall 12-17 years of IT experience and 7year 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.