Manufacturing Ops Project Management Specialist

1000 Merck Sharp & Dohme LLC; North Carolina; On-site; USD 79,000 - 125,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical insurance

Dental insurance

Vision insurance

401(k)

Job summary

MSD in Durham, NC is seeking a Specialist, Operations (Project Management) to coordinate project activities, maintain accurate information, support change controls and incident writing, and help teams complete actions to support PAI and filing readiness.

You will work across Operations, Quality, Engineering, Regulatory, and other functions, reporting to project leaders, with a focus on scheduling, governance, and continuous improvement in a regulated manufacturing environment.

Qualifications

• Bachelor's degree in Engineering, Science, Business, Project Management, or a related field.
• Minimum of two years of relevant experience in manufacturing, operations, quality, engineering, project management, or a related regulated environment.
• Demonstrated written and verbal communication skills, including the ability to create clear technical or business documentation.
• Ability to work independently, manage competing priorities, and elevate issues with clear recommendations.

Responsibilities

• Readiness Support Pre-Approval Inspection (PAI) and filing-readiness plans by tracking deliverables, owners, due dates, dependencies, and open actions.
• Maintain project and portfolio records, including project status, priorities, milestones, risks, resource needs, and dependencies.
• Coordinate Change Review Board logistics, agenda, intake tracking, and minutes with cross-functional partners.
• Author and coordinate incident and deviation records; support root-cause analysis and corrective actions.
• Develop and maintain integrated project schedules; produce routine schedule and milestone reporting.

Skills

Adaptability

cGMP compliance

Coaching

Column chromatography

Communication

Computer literacy

Continuous improvement

Data analysis

Data integrity

Engineering document management

EHS management

Equipment setup

GMP

Inspection readiness

Lean manufacturing tools

Learning agility

Manufacturing

Microsoft Project

Pre approvals

Process monitoring

Process optimization

Process troubleshooting

Product delivery

Project planning

Education

Bachelor's degree in Engineering, Science, Business, Project Management, or related field

Tools

Microsoft Project

Lean Six Sigma

Job description

MSD in Durham, NC is seeking a Specialist, Operations (Project Management) to coordinate project activities, maintain accurate information, support change controls and incident writing, and help teams complete actions to support PAI and filing readiness.

You will work across Operations, Quality, Engineering, Regulatory, and other functions, reporting to project leaders, with a focus on scheduling, governance, and continuous improvement in a regulated manufacturing environment.