Specialist, Engineering Projects

MSD•Upper Gwynedd Township, PA

23h•$87,300 - $137,400•Onsite

About The Position

The West Point ROTA E2E organization is seeking a highly motivated Specialist, Engineering to join the ROTA E2E Strategic Projects Technical Operations team. The role provides end-to-end technical support for commercial vaccine products within the ROTA Organization and contributes to the performance and results of multiple vaccine manufacturing and packaging areas. The incumbent provides technical guidance, anticipates and interprets customer needs, and identifies and implements solutions. The position supports and leads continuous improvement and process-performance projects, including initiatives that strengthen compliance, simplify and standardize processes, improve Right-First-Time performance, reduce deviations and costs, increase yield and efficiency, and shorten processing cycle times. It also provides advanced and on-the-floor technical support for complex manufacturing process and equipment issues, supports investigations and root-cause resolution, and contributes to safety, environmental, and regulatory objectives. The Specialist collaborates with manufacturing colleagues, support teams, Quality, Planning, project teams, and external vendors; manages project schedules; designs and reviews experimental protocols; prepares and maintains technical and manufacturing documentation; and supports regulatory inspections. The role is based in West Point, Pennsylvania, with a first-shift schedule. The position is regular, with no travel or relocation offered.

Requirements

Bachelor's degree in engineering or another equivalent technical field.
At least two years of post-bachelor's experience in a GMP-regulated functional area or supporting a GMP-regulated function, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
Experience supporting change control activities and/or project execution.
Strong communication, leadership, and teamwork skills.
Ability to manage projects and assignments effectively while meeting established schedules and deadlines.
Skills listed include adaptability, analytical instrumentation, bioprocessing, cGMP compliance, change control processes, change controls, computerized maintenance management systems (CMMS), continuous improvement techniques, customer needs identification, data analysis, attention to detail, engineering document management, engineering principles, maintenance supervision, manufacturing, mechanical systems, process control, process simplification, process standardization, production support, project management, project time management, and regulatory compliance and inspections.

Nice To Haves

Experience serving as a Change Control author and/or reviewer.
Experience working in biologics, vaccine, bulk sterile manufacturing, or another GMP-regulated manufacturing facility.
Project management experience.

Responsibilities

Support, execute, and/or lead continuous improvement projects to increase compliance, simplify and standardize processes, and improve operational efficiency.
Complete and/or lead projects to enhance process performance, including CAPA investigations, Right-First-Time initiatives, deviation reduction, and value-capture projects focused on yield, efficiency, cost reduction, and shorter processing cycle times.
Manage project timelines to meet compliance requirements and customer deadlines, escalate potential delays, and develop remediation plans.
Collaborate with Coaches, Operators, Mechanics, support teams, Quality, Planning, project teams, and external equipment and component vendors.
Assess complex issues from safety, compliance, automation, equipment, process, and personnel perspectives to identify and resolve root causes.
Provide advanced technical support to manufacturing operations for complex process- and equipment-related issues.
Design, conduct, review, and approve experimental protocols using Technical Operations laboratory facilities and/or full-scale production equipment, as needed.
Author, update, and review technical and manufacturing documentation for engineering studies and change control activities.
Support regulatory inspection activities.
Provide on-the-floor support for complex operational and technical issues involving processes and equipment.
Support team objectives related to safety, environmental standards, and regulatory compliance.