GMP/Annex 1 CAPEX Project Lead – Onsite, Long-Term

i-Pharm GxP

Illinois

On-site

USD 83,000 - 138,000

Full time

6 days ago

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Benefits offered by this job

Hourly rate with expenses covered

Job summary

i-Pharm GxP in Illinois is seeking an experienced CAPEX Project Manager with a strong background in pharmaceutical manufacturing, GMP compliance, and EU Annex 1. The role focuses on a multi-year sterile manufacturing remediation and upgrade programme onsite at the existing facility.

You will drive cross-functional coordination across Engineering, Quality, C&Q, CSV, Manufacturing, and external contractors, manage scope, schedule, risks, and handover, and ensure strict adherence to GMP and EU

Qualifications

PM experience in highly regulated pharma or GMP environments.
Hands-on EU Annex 1 compliance or sterile facility upgrade exposure.
Strong understanding of engineering design, C&Q, CSV, and quality processes.
Excellent stakeholder management and cross-functional leadership.

Responsibilities

Own & deliver workstreams across a major facility remediation programme.
Cross-Functional Coordination: Drive alignment across Engineering, Quality, C&Q, CSV, Manufacturing, and external contractors.
Lifecycle Management: Oversee project scope, schedule, risks, and deliverables from design reviews through to procurement, construction, commissioning, and handover.
Compliance Oversight: Ensure all projects strictly adhere to current GMP and EU Annex 1 requirements for sterile manufacturing and contamination control.