What are the responsibilities and job description for the Senior Project Manager position at i-Pharm GxP?
Project Overview
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 one Senior Project Manager with considerable experience in:
- Design management and review
- Commissioning
- Qualification
The Senior Project Manager will lead execution activities associated with the defined project scopes and will report to the Project Engineering Program Director.
Project Scopes
The Senior Project Manager will manage the team associated with 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
- Site Unidirectional MALs & PALs
- 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 accordance with the client’s project delivery requirements for Tier 2 and Tier 3 projects.
- Oversee the generation, review and approval of documentation related to the project master schedule.
- Maintain and update document trackers.
- Manage day-to-day activities of resources within assigned workstreams.
- Ensure deliverables are completed on time and in compliance with 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
- Commissioning
- Qualification
Project Schedule
- Start: October 2026
- End: December 2028
- Coverage: Project Planning, Detail Design through Project Completion