Specialist, Engineering Projects

MSD

Upper Gwynedd Township (Montgomery County)

On-site

USD 87,000 - 137,000

Full time

8 days ago

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Benefits offered by this job

Medical

Dental

Vision insurance

401(k)

Paid holidays

Vacation

Sick days

Job summary

MSD is seeking a Specialist, Engineering for the West Point ROTA E2E Strategic Projects Technical Operations team. This role delivers end-to-end technical support for vaccine products and guides multiple manufacturing and packaging areas to improve yield, efficiency, and compliance.

Responsibilities include leading improvement projects, managing timelines, collaborating with cross-functional teams, and supporting change control and regulatory activities.

Qualifications

Bachelor’s degree in engineering or equivalent.
Minimum two years post-bachelor GMP experience.
Experience with change control and project execution.

Responsibilities

Lead continuous improvement projects for compliance and efficiency.
Manage project timelines to meet deadlines.
Collaborate with operators, quality, planning, and vendors.
Provide advanced technical support to manufacturing operations.
Develop and review experimental protocols.
Support regulatory inspections.

Skills

GMP compliance

Project management

Change control

Effective communication

Data analysis

Root cause analysis

Education

Bachelor's degree in engineering

Tools

CMMS

Job description

Job Description

The West Point ROTA E2E organization is seeking a highly motivated individual for the role of Specialist, Engineering within the ROTA E2E Strategic Projects Technical Operations team. This role will provide end-to-end technical support for commercial vaccine products within the ROTA Organization. The incumbent will have the opportunity to contribute to the performance and results of multiple Vaccine manufacturing and Packaging areas by providing technical guidance and anticipating and interpreting customer needs to identify and implement solutions.

Position Responsibilities

Support, execute, and/or lead continuous improvement projects aimed at increasing compliance, simplifying and standardizing processes, and improving operational efficiency. May work independently, as part of a team, or as a project lead.
Complete and/or lead projects designed to enhance process performance. This includes investigating Corrective and Preventive Actions (CAPAs), initiatives to improve Right-First-Time performance, reduce deviations, and execute value-capture projects focused on improving yield and efficiency, reducing costs, or shortening processing cycle times.
Manage project timelines to ensure compliance requirements and customer deadlines are met. Escalate potential delays and develop remediation plans as needed.
Collaborate effectively with Coaches, Operators, Mechanics, support teams, Quality, Planning, project teams, and external equipment and component vendors.
Examine complex issues from multiple perspectives, including safety, compliance, automation, equipment, process, and personnel considerations, to identify and effectively resolve root causes.
Provide advanced technical support to manufacturing operations for complex process- and equipment-related issues.
Design, conduct, review, and approve experimental protocols as needed, utilizing Technical Operations laboratory facilities and/or full-scale production equipment.
Author, update, and review technical and manufacturing documentation required 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.

Education Minimum Requirement

Bachelor’s degree in engineering or other equivalent technical field

Required Experience and Skills

Minimum of two (2) years of post-bachelor’s degree experience in a GMP-regulated functional area or in support of 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.
Demonstrated ability to manage projects and assignments effectively while meeting established schedules and deadlines.

Preferred Experience and Skills

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

Required Skills

Adaptability
Adaptability
Analytical Instrumentation
Bioprocessing
cGMP Compliance
Change Control Processes
Change Controls
Computerized Maintenance Management Systems (CMMS)
Continuous Improvement Techniques
Customer Needs Identification
Data Analysis
Detail-Oriented
Engineering Document Management
Engineering Principle
Maintenance Supervision
Manufacturing
Mechanical Systems
Process Control
Process Simplification
Process Standardization
Production Support
Project Management
Project Time Management
Regulatory Compliance
Regulatory Inspections

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

Hazardous Material(s)

N/A

Job Posting End Date

10/31/2026

Compensation

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$87,300.00 - $137,400.00

This range reflects the Company’s reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.