Validation Project Manager

Overview

Validation Project Manager (Finance) – Reporting to the Quality Assurance (QA) Manager or equivalent manager/supervisor, the Validation Project Manager (VPM) is responsible for assisting the QA Manager (or equivalent manager/supervisor) and Validation Engineering team in ensuring the quality/validation system requirements are met and maintained. The Project Manager is responsible for managing and overseeing validation projects for the plant, including resource utilization and day-to-day tracking of these projects.

This includes working with Sterigenics and Nelson Labs internal staff and systems to ensure all the information for projects to be started, prioritized, and tracked are in place. Additionally, the Project Manager facilitates regular meetings and communications with the sponsor and the facility, to ensure projects are progressing and tracking to timeline and budget. The Project Manager provides general overview of group capacities to the consulting/sales teams and communicates when significant issues arise that have the potential to adversely affect the success of projects.

The Project Manager is the point of contact for all stakeholders in a project. The VPM must effectively interface with the Validation Team, Customer Service, Sales, Operations, Laboratory (if any), and Quality, and other plant and corporate staff, as well as customers. The VPM will also train as a Validation Technician (VT) and perform those duties as time permits.

• Ensure validation project processes are tracked and reported.
• Update and improve the project management processes.
• Draft and execute project plans that meet company/customer requirements and objectives.
• Facilitate reoccurring project and team meetings.
• Identify needs by working with area managers to secure and schedule project resources.
• Regularly review projects to ensure projects are progressing towards completion.
• Prepare information and facilitate on-site client visits pertaining to validation work.
• Project issue identification, mitigation and resolution generation.
• Manage day-to-day operational aspects of assigned projects
• Effectively communicate relevant project information to internal and external stakeholders
• Professional level of communication to internal and external clients (written and verbal)
• Ability to assess when to escalate issues ensuring a timely resolve
• Hold regular status meetings with project team
• Keep project team well informed of changes
• Ensure validation project tasks within CRM (or other primary project management system) is complete and kept up to date in a timely manner

• Performs routine equipment calibrations (as required) and maintain history records.
• Responsible for load preparation in collaboration with the validation engineer team.
• Document and record process readings and constructing data packets.
• Responsible for specific aspects of validation protocols and technically driven customer projects, which include but are not limited to the following
• Assists with other tasks as assigned by Supervisor and other Validation Engineering team.

• B.S./B.A. degree and two years relevant experience or 4 years of equivalent and relevant experience. PMP certificate preferred.
• 2-3 years of experience managing multiple technical projects or similar competencies.
• Minimum of one (1) year of experience working in a sterilization or medical manufacturing manufacturer environment with GMP/GLP knowledge preferred.
• Must be able to read, write and speak fluent English (US Facilities).
• Professional and verbal and written communication skills.
• Computer skills:
  Microsoft Office applications.
• Must be able to lift a maximum of 50 pounds (23kg) and perform repetitive bending and lifting motions over a period of time.
• Forklift driving experience preferred, however internal training will be given.
• Must be able to travel 5-10% to various locations as needed.

• Must be able to tolerate exposure to high temperatures and high humidity [up to 130F (55C) and 65% RH for 20 minutes] (EO).

• Must complete all required training for validation internal…