Specialist, Operations (Project Management)

Job Description

Our Manufacturing Operations teams make and supply products with a Safety First Quality Always Inclusion for All mindset and a focus on continuous improvement. Team members work within the local plant and across the global manufacturing network to support reliable compliant delivery of high-quality materials and finished products.

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 to support PAI and filing. The role works with Operations Quality Engineering Technical Operations Automation Regulatory and other functions while receiving direction and coaching from project leaders and subject matter experts.

PAI and Filing Readiness

• Support Pre-Approval Inspection (PAI) and filing-readiness plans by tracking deliverables owners due dates dependencies and open actions.
• Update readiness trackers and dashboards so milestones risks gaps and recovery actions are visible and current.
• Coordinate meetings prepare materials document decisions and follow up with owners on assigned actions.
• Help organize inspection evidence procedures training records and filing-related documents for review by subject matter experts.
• Raise schedule documentation or compliance concerns promptly to the project manager or workstream lead.

Project Portfolio Management

• Maintain project and portfolio records including project status priorities milestones risks resource needs and dependencies.
• Support project intake and portfolio review activities by gathering information and preparing standard summaries.
• Prepare status reports and dashboards using approved templates and data sources.
• Assist project leads with charters action logs risk registers and project closeout documentation.
• Promote accurate timely updates across project tools and reporting routines.

Change Review Board Leadership

• Coordinate Change Review Board (CRB) logistics including agenda preparation intake tracking meeting materials minutes and action follow-up.
• Gather required information from cross-functional partners to support assessment of proposed changes.
• Document decisions conditions owners and due dates clearly and accurately.
• Track changes and open actions through implementation and closure; escalate overdue or blocked items.
• Support updates to CRB templates metrics and standard work.

Incident Writing and Investigation Support

• Author and coordinate incident and deviation records in partnership with Operations Quality Engineering Technical Operations and other subject matter experts.
• Build clear fact-based event narratives and support problem definition impact assessment root-cause analysis corrective and preventive actions and on-time record progression.
• Facilitate investigation working sessions track information requests and approvals and maintain visibility to investigation milestones and potential delays.
• Apply strong technical writing practices to ensure records are concise accurate traceable and aligned with applicable procedures and cGMP expectations.

Project Scheduling and Operational Excellence

• Develop and maintain integrated project schedules that include activities logic dependencies milestones critical paths constraints and resource assumptions.
• Partner with workstream leads to update progress evaluate schedule impacts identify recovery options and communicate forecast changes.
• Produce routine schedule and milestone reporting for project teams and governance forums with emphasis on 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.

Core Competencies

• Project coordination organization facilitation and action tracking.
• Clear written and verbal communication.
• Basic schedule risk and dependency management.
• 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.

Qualifications.

Required Education Experience and Skills

• Bachelors 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 escalate issues with clear recommendations.

Preferred Experience and Skills

• Experience working 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. #EBRGS #VetJobs #SWE2026

Work Expectations

• Periodic off-shift or weekend support may be required based on business needs inspection-readiness activities incident response or project milestones.
• Travel: Up to 10% based on business needs.

Required Skills:

Adaptability Adaptability cGMP Compliance Coaching Column Chromatography Communication Sciences Computer Literacy Continuous Improvement Techniques Data Analysis Data Integrity Engineering Document Management Environmental Health and Safety (EHS) Management Equipment Set Up Good Manufacturing Practices (GMP) Inspection Readiness Lean Manufacturing Tools Learning Agility Manufacturing Microsoft Project Pre Approvals Process Monitoring Process Optimization Process Troubleshooting Product Delivery Project Planning 9 more

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

The primary location for this posting is:

USA - North Carolina - Durham (Old Oxford)

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

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

$79200.00 - $124700.00

This range reflects the Companys reasonable expectation of the base salary applicable to this role at the time of posting. An employees 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. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at 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

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

11/18/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.