Mv01-050224 Senior Project Manager

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Senior Project Manager

Ideal Candidate:

• Support to process development. Needs to have at least 5 years of experiece in Biotech, Medical Devices, or Pharma industries. Experience with GMP environment.

• Technical degree preferred: Engineering open to chemical, mechanical, etc.

• Candidate should showcase they have executed projects took ownership full lifecycle.

• Ideally smart sheets, MS Project, or other PM tools.

This role serves as project manager for Final Drug Product New Process Introductions (NPI). NPI scope may include the implementation of various drug product formats (e.g. vial, syringe, auto injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.

The Project Manager engages Final Drug Product development teams throughout the commercialization process, leading cross-functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Process Development and other business groups.

Primary responsibilities include assessment of NPIs for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities.

Day to Day Responsibilities:

• Work with various NPI support groups to develop, maintain, and execute the NPI project plan and is accountable for NPI scope, schedule, resources, and risk management.

• Issue resolution in a timely manner and escalation to various levels of management as appropriate.

• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.

• Manage change control and coordinate with various functions to ensure success initiation, execution, and implementation of the change records.

• Familiar with project management tools (Smartsheet preferred) and proven records of successfully leading multiple projects at the same time.