Specialist Engineering - Incoming Materials

MSD•Upper Gwynedd Township, PA

8d•$87,300 - $137,400•Hybrid

About The Position

Our company aspires to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and use the power of leading-edge science to save and improve lives around the world. West Point, PA Technical Operations for the Incoming Materials (IM) team is seeking a highly motivated individual for a Specialist, Engineering position. The successful candidate will partner with Suppliers, IM Quality, Planning, Procurement, Validation, Warehouse, Supplies Inspection, Global IM Tech Ops, Supplier Development & Performance Development, and Supplier Quality Management to ensure that the incoming materials used across the West Point site support the manufacture of the highest quality vaccines.

Requirements

Bachelor’s Degree or higher (Engineering or Sciences, preferred)
Minimum two (2) years post-bachelor’s degree experience in GMP manufacturing/laboratories and/or technical support of GMP manufacturing operations/laboratories.
Experience in change control and/or project support role.
Highly developed communication, leadership, and teamwork skills.
Ability to manage projects/work to schedule/deadlines.

Nice To Haves

Experience in biologics, vaccine, or bulk sterile manufacturing facilities.
Change Control author
Supplier Change Notification experience
Project Management
Technical Writing

Responsibilities

Execute change management for supplier-initiated changes and site-initiated incoming material projects.
Author and update GMP technical documents and SOPs to support incoming material qualification and change control.
Design and conduct experimental protocols to support incoming material qualification, testing, and improvement projects.
Provide technical support for Warehouse, Supplies Inspection, and incoming materials used in manufacturing areas across the West Point site.
Lead or support execution of Quality Risk Assessments.
Support regulatory inspection activities for the facility.
Support IM Deviation Management team investigations and Corrective/Preventative Actions (CAPAs) if necessary. Improve Right-First-Time performance and prevent/reduce deviations.
Support and/or execute continuous improvement projects to increase compliance, simplify/standardize processes, resolve release issues, and gain efficiencies.
Manage project timelines to ensure key compliance and customer due dates are met; escalate potential delays, and develop remediation plans when possible.
Support team safety, environmental, and compliance objectives.