Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
Able to Provide Sponsorship
Skills
Program Manager
Job Details
- Overall 15 + 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.
- 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.
- Develop validation strategy and execute CSV planning across complex digital systems.
- Embed GxP (21 CFR Part 11, Annex 11) requirements early during design.
- 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
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.
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