Senior Specialist, Operations
Merck
August 13, 2026
On-site
Durham, NC
Operations
Senior Operations Specialist (Operations Manufacturing Support)
Responsibilities:
- Support end-to-end product Value Stream Map to drive production improvements, inventory management, cost reductions, and standard work.
- Collaborate with Operations, Technology, and Quality to author regulatory inspection observation responses and complete remediation projects.
- Assist shift managers with leadership to the production floor; provide primary leadership during manager absence.
- Serve as liaison to support groups to resolve day-to-day issues and support projects (including tech transfer).
- Author/own Operations protocols; develop/own Operations corrective actions.
- Author/revise Standard Operating Procedures (SOPs).
- Support internal/external regulatory inspections and present as needed.
- Execute/manage Operations batch record review within release timelines; liaison with Quality to resolve comments.
- Act as Day shift Operations representative; lead/support production and quality projects and process improvements.
- Lead problem-solving of real-time shop floor issues; support investigations of process deviation events.
- Provide production floor expertise (safety, compliance, equipment, regulatory); work independently with shifting priorities and minimal direction.
Education (minimum):
- Bachelor’s degree (science/chemical, mechanical, or electrical engineering preferred); B.S. in Engineering or Science fields strongly preferred.
Required experience/skills:
- 5+ years in manufacturing/technical/mechanical support in a high-volume lean operation.
- Technical writing (investigations, change requests, SOPs, batch records, protocols).
- Works independently and in cross-functional teams in a fast-paced environment.
Preferred:
- Sterile manufacturing shop floor, cGMP and vaccine/pharma regulatory knowledge.
- Root cause analysis / Lean Six Sigma; SAP/MRP/ERP and electronic batch record systems.
- Presenting to internal/regulatory auditors; Excel/Minitab/JMP/statistical analysis; Six Sigma certification.
Benefits (as stated):
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply no later than 08/27/2026 (effective until 11:59:59PM the day before). Requisition ID: R412627.
Responsibilities:
- Support end-to-end product Value Stream Map to drive production improvements, inventory management, cost reductions, and standard work.
- Collaborate with Operations, Technology, and Quality to author regulatory inspection observation responses and complete remediation projects.
- Assist shift managers with leadership to the production floor; provide primary leadership during manager absence.
- Serve as liaison to support groups to resolve day-to-day issues and support projects (including tech transfer).
- Author/own Operations protocols; develop/own Operations corrective actions.
- Author/revise Standard Operating Procedures (SOPs).
- Support internal/external regulatory inspections and present as needed.
- Execute/manage Operations batch record review within release timelines; liaison with Quality to resolve comments.
- Act as Day shift Operations representative; lead/support production and quality projects and process improvements.
- Lead problem-solving of real-time shop floor issues; support investigations of process deviation events.
- Provide production floor expertise (safety, compliance, equipment, regulatory); work independently with shifting priorities and minimal direction.
Education (minimum):
- Bachelor’s degree (science/chemical, mechanical, or electrical engineering preferred); B.S. in Engineering or Science fields strongly preferred.
Required experience/skills:
- 5+ years in manufacturing/technical/mechanical support in a high-volume lean operation.
- Technical writing (investigations, change requests, SOPs, batch records, protocols).
- Works independently and in cross-functional teams in a fast-paced environment.
Preferred:
- Sterile manufacturing shop floor, cGMP and vaccine/pharma regulatory knowledge.
- Root cause analysis / Lean Six Sigma; SAP/MRP/ERP and electronic batch record systems.
- Presenting to internal/regulatory auditors; Excel/Minitab/JMP/statistical analysis; Six Sigma certification.
Benefits (as stated):
- Medical/dental/vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
Application:
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Apply no later than 08/27/2026 (effective until 11:59:59PM the day before). Requisition ID: R412627.