MES Project Manager GMP-Regulated Manufacturing

Katalyst-Healthcares-

City of Albany (NY)

On-site

USD 120,000 - 160,000

Full time

13 days ago

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Job summary

Katalyst-Healthcares- is seeking an experienced MES Project Manager to lead end-to-end MES implementations, upgrades, and enhancements in GMP‑regulated environments. This role demands strong MES expertise, project management, and a track record in life sciences manufacturing.

You will manage cross-functional teams, develop robust project plans, ensure CSV/data integrity, and coordinate with IT, QA, Validation, and external vendors to deliver on schedule and within budget.

Qualifications

  • Experience leading MES projects in pharmaceutical/manufacturing environments.
  • Knowledge of GMP/GxP, CSV, data integrity, and regulated system documentation.
  • Proven ability to plan, manage risks, engage stakeholders and coordinate vendors.

Responsibilities

  • Lead end-to-end MES projects including implementation, upgrade and deployment.
  • Develop and manage plans, timelines, budgets, resources, deliverables, and risks.
  • Coordinate cross-functional teams across Manufacturing, QA, Validation, IT, and vendors.

Skills

MES
Project management
GMP
CSV
Vendor coordination
Cross-functional leadership

Education

Bachelor's degree in engineering / CS / IT / Pharmaceutical Sciences or related field
Master's degree in engineering / PM / IS or related

Tools

EBR systems
ERP integration
LIMS integration
SCADA systems

Job description

Katalyst-Healthcares- is seeking an experienced MES Project Manager to lead end-to-end MES implementations, upgrades, and enhancements in GMP‑regulated environments. This role demands strong MES expertise, project management, and a track record in life sciences manufacturing.

You will manage cross-functional teams, develop robust project plans, ensure CSV/data integrity, and coordinate with IT, QA, Validation, and external vendors to deliver on schedule and within budget.

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