Engineering Specialist

MSD•Upper Gwynedd Township, PA

2d•Hybrid

About The Position

Engineering Specialist - Live Vaccine Bulk Manufacturing Projects Team The West Point Technical Operations organization is seeking a highly motivated individual for a Specialist – Engineering position within our company's vaccine Bulk Projects team. The successful candidate will contribute to the planning and execution of strategic projects by contributing technical leadership and interpreting project needs to identify and implement solutions. Responsibilities may include technical assessments, protocol execution on the shopfloor, and equipment commissioning/qualification assistance to ensure robust strategic project execution within the West Point site.

Requirements

B.S. or M.S. degree in Engineering related or Science related fields.
Minimum 2 years post-bachelor’s degree experience in GMP manufacturing, technical support of GMP manufacturing operations, or other design-based experience.
Experience in project support and/or change control and/or deviation management and/or manufacturing support role.
Experience with biologics or vaccine manufacturing facilities.
Strong technical problem-solving and critical thinking abilities.
Willingness to proactively speak up and contribute ideas, even in situations of uncertainty or incomplete information.
Ability to respectfully challenge others’ views, including those of stakeholders, to advocate for the team’s goals.
Developed written and verbal communication, leadership, and teamwork skills.
Adaptability
Change Control Management
Collaborative Development
Data Analysis
Equipment Troubleshooting
Flexibility
GMP Compliance
Good Manufacturing Practices (GMP)
Manufacturing Processes
Oral Communications
Personal Initiative
Process Optimization
Professional Integrity
Project Engineering
Project Management
Project Management Support
Quality Risk Assessment
Root Cause Analysis (RCA)
Technical Leadership
Technical Writing
Technology Transfer
Vaccine Manufacturing
Writing Technical Documents

Nice To Haves

Understanding of sterile and aseptic processing.
Experience in a facility start-up.
Experience with equipment and/or facility commissioning, qualification, and validation.
Proficient in the following competencies: flexibility, motivation, teamwork/collaboration, and problem-solving.

Responsibilities

Executes technical work required for strategic projects at our West Point location to align with department, site, and franchise objectives.
Supports team safety, environmental, and compliance initiatives.
Contributes as a team member on collaborative tasks such as timeline planning sessions, area layout programming, technical assessments of process and equipment design, and presentations to project- and site-based leadership teams.
Authors and updates technical and manufacturing documents, for example process design/definition, technical protocols, or equipment qualification.
Executes projects from concept to qualification, which may involve facilities, utilities, equipment, automation, or process-related changes based on project requirements.
Performs tasks related to technology transfer planning.
Leads or participates as a team member on quality risk assessments.
Gains intimate knowledge of the bulk manufacturing process through spending time on the shopfloor.
Collaborates with subject matter experts and stakeholders outside the core project team as necessary to achieve project needs.
Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans when possible.
Prepares documentation to support regulatory submission and participates in regulatory inspection activities, as needed.
Examines issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve challenges.
Promotes open communications and teamwork.
Effectively collaborates with cross-functional peers.