Project Engineer-Medical Device

1 month ago

Thousand Oaks, United States Infotree Global Solutions Full time

chedule is typically 8am - 5pm

some flexibility with schedule, may be expected to work OT 10% of the time during peak season (Q4)


Ideal candidate: Biotech and pharma GMP environment. Combination products, English written and verbal skills, MS Office, SmartSheets project scheduling software, Project management skills in a supporting role.


PMP certification is desired


Let’s do this. Let’s change the world. In this dynamic role you will organize Technology Transfer activities for Final Drug Product manufacturing. Supporting and creating project schedules, dashboards and leading team meetings to progress the project final objectives. This will include working across a global and cross functional team consisting of manufacturing, device and packaging design for combination product, capital projects, physical test methods, quality and regulatory team members. To effectively serve patients, we build effective Technology Transfer plan and schedule for our combination products that enhance end to end controls with robust methods with data flow to our digital infrastructure in a GMP setting. Responsibilities of this position may include:


Supporting Tech Transfer project scheduling activities for FDP;

Support New Product Introduction to client manufacturing site;


Owning documentation such as Project Plan, supporting engineering with PTD (Process Transfer Document), Protocols and reports;


Supporting engineers with M-a-B (Make-a-Batch) activities to make sure the sending/receiving sites expectation are met;


Developing, tracking and providing project dashboard updates;


Providing good communication plan to cross functional team and Process Engineer management;


Ability to apply project management and engineering science to production;


Strong teamwork, excellent interpersonal and communication skills;



Basic Qualifications:


Master degree OR

Bachelor degree and 2 years of experience OR

Associate degree and 6 years of experience OR

High school diploma / GED and 8 years of experience

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