Project Manager

i-Pharm GxP; Illinois; On-site; USD 140,000 - 180,000; Full time

Job summary

i-Pharm GxP seeks two Project Managers in Illinois to drive a Site Sterility Assurance Program aligned with EU Annex 1 requirements.

You will lead design management and qualification across multiple scopes and remain engaged through project completion in 2028, coordinating with client SMEs, A&E partners, and CM groups. You will generate GxP Assessments, Project Execution Plans, and User Requirement Briefs, ensuring deliverables meet schedule and quality standards for Tier 2/3 projects.

Qualifications

• 10+ years of experience in design management and qualification.
• Experience leading complex pharmaceutical design reviews.
• Ability to coordinate cross-functional teams with SMEs and vendors.

Responsibilities

• Lead assigned project design management activities and design reviews.
• Collaborate with client SMEs, A&E partners and Construction Management groups.
• Generate GxP Assessments, Project Execution Plans and User Requirement Briefs.

Skills

Design management

Qualification

Job description

A major pharmaceutical manufacturer has initiated a Site Sterility Assurance Program to comply with EU Annex 1 requirements across its facilities and systems.

The program is intended to design and deliver qualified and validated existing pharmaceutical manufacturing facilities and processes by fiscal year 2028. The scope includes transitional spaces, changing rooms, HVAC improvements, process improvements including Single Bag Use, PUPSIT and CCIT, environmental controls, and other related remediation activities.

Position

The client requires two Project Managers with considerable experience in:

• Design management and review
• Qualification

The Project Managers will lead assigned project scopes within the program and are expected to remain committed through project completion in 2028.

Project Scopes

Project Managers may be assigned across one or more of the following project scopes:

• CCIT Install & Qualification
• B16N Compliance and Improvement
• B16N Aseptic Installation of Needles
• B16 Grade C Pass-Through Improvement
• B16N Compliance and Improvement
• PUPSIT Compliant Sterile Filtration
• CNC Halls and Change Rooms
• Dispensing and Sampling Environment Upgrade
• B16N Washroom Expansion
• Site Execution

Key Responsibilities

• Lead assigned project design management activities and design reviews.
• Collaborate with client SMEs, A&E partners and Construction Management groups.
• Lead and/or participate in the generation of:
• GxP Assessments
• Project Execution Plans
• User Requirement Briefs
• Oversee Project Engineering activities in line with the project delivery requirements for Tier 2 and Tier 3 projects.
• Support the generation, review and approval of documentation linked to the project master schedule.
• Maintain and update document trackers.
• Manage the day-to-day activities of resources within assigned workstreams.
• Ensure project deliverables are completed on time and in compliance with required standards.
• Manage and communicate deliverables, risks and requirements with project teams and stakeholders.
• Ensure Project Engineering, C&Q and CSV deliverables are met.
• Manage additional deliverables as required by the client.

Experience Requirements

• 10+ years of experience

Demonstrated experience in:

• Design management and review
• Qualification
• Candidates without previous experience within the client’s network must provide references demonstrating the required experience.
• Selected candidates may be interviewed by members of the project team.

Project Schedule

• Start: October 2026
• End: December 2028
• Coverage: Project Planning, Detail Design through Project Completion