Specialist, Operations (Project Management)

Merck•Durham, NC

1d•$79,200 - $124,700•Onsite

About The Position

The Specialist, Operations (Project Management) supports the Durham manufacturing site by coordinating project activities, maintaining accurate project information, supporting change controls and incident writing, and helping teams complete actions for Pre-Approval Inspection (PAI) and filing readiness. The role collaborates with Operations, Quality, Engineering, Technical Operations, Automation, Regulatory, and other functions, receiving direction and coaching from project leaders and subject matter experts. The position supports PAI and filing readiness, project portfolio management, Change Review Board coordination, incident and deviation writing and investigation support, project scheduling, and operational excellence. It maintains project records and schedules, tracks deliverables and actions, prepares reports and meeting materials, supports change and investigation documentation, and raises schedule, documentation, or compliance concerns. The role also participates in site operational routines and continuous-improvement initiatives. The position is based primarily at the Durham, North Carolina manufacturing site. Periodic off-shift or weekend support may be required based on business needs, inspection-readiness activities, incident response, or project milestones. Travel is up to 10%. The role is a regular employee position on the 1st (day) shift. The listed salary range for the primary location is $79,200 to $124,700, with eligibility for an annual bonus and long-term incentive if applicable.

Requirements

Bachelor's degree in Engineering, Science, Business, Project Management, or a related field.
At least 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 escalate issues with clear recommendations.
Project coordination, organization, facilitation, and action-tracking skills.
Clear written and verbal communication.
Basic schedule, risk, and dependency management skills.
Attention to detail and commitment to data integrity.
Ability to collaborate across functions, ask questions, and escalate concerns appropriately.
Adaptability, learning agility, and a continuous-improvement mindset.

Nice To Haves

Experience in pharmaceutical, biologics, vaccine, medical device, or other regulated manufacturing environments.
Familiarity with inspection readiness, regulatory filings, change control, deviations, investigations, or CAPAs.
Experience with Microsoft Project or similar planning and tracking tools.
Basic knowledge of cGMP, root-cause analysis, FMEA, Lean, or Six Sigma methodologies.
Lean Six Sigma certification or comparable project management or continuous-improvement training.

Responsibilities

Track PAI and filing-readiness deliverables, owners, due dates, dependencies, and open actions; maintain readiness trackers and dashboards.
Coordinate meetings, prepare materials, document decisions, follow up on actions, and help organize inspection evidence, procedures, training records, and filing documents.
Promptly raise schedule, documentation, or compliance concerns to the project manager or workstream lead.
Maintain project and portfolio records, including status, priorities, milestones, risks, resource needs, and dependencies.
Support project intake and portfolio reviews by gathering information and preparing standard summaries.
Prepare status reports and dashboards using approved templates and data sources; assist with project charters, action logs, risk registers, and closeout documentation.
Coordinate Change Review Board logistics, including agenda preparation, intake tracking, meeting materials, minutes, and action follow-up.
Gather cross-functional information to assess proposed changes and document decisions, conditions, owners, and due dates.
Track changes and open actions through implementation and closure, escalate overdue or blocked items, and support updates to CRB templates, metrics, and standard work.
Author and coordinate incident and deviation records with Operations, Quality, Engineering, Technical Operations, and subject matter experts.
Develop fact-based event narratives and support problem definition, impact assessment, root-cause analysis, corrective and preventive actions, and timely record progression.
Facilitate investigation working sessions, track information requests and approvals, and monitor investigation milestones and potential delays.
Ensure incident and deviation records are concise, accurate, traceable, and aligned with applicable procedures and cGMP expectations.
Develop and maintain integrated project schedules covering activities, logic, dependencies, milestones, critical paths, constraints, and resource assumptions.
Partner with workstream leads to update progress, assess schedule impacts, identify recovery options, and communicate forecast changes.
Produce routine schedule and milestone reporting for project teams and governance forums, emphasizing exceptions and decisions required.
Support continuous-improvement initiatives that strengthen planning, governance, cycle time, right-first-time performance, and execution reliability.
Participate in site tier processes, gemba walks, readiness reviews, and other operational routines as assigned.