Posting Title: Project Engineer / Pharma – Med Space / NPI

Title: Engineer Senior

Location: New Albany, OH

Duration: 12 Months

Description:

100% onsite for OH New Albany site.

Ideal candidate: Engineer or other technical background (mechanical, industrial, chemical...etc.). Experience leading technical projects from start to finish. supporting process development. Biotech, med device, pharmaceuticals or other GMP manufacturing experiences preferred. Min. 3 years of experiences preferred. 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) into Ohio. 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 NPI’s 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.

Must Have Skill:

Project Management,

communication,

work in teams

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. Responsibilities include 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.