Validation Project Manager

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.

Responsibilities/Duties


* 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

Additional Responsibilities/Duties


* 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 specifi...