Senior Specialist, Vaccines Technology
Merck
September 02, 2026
Remote friendly (Wilson, NC)
United States
Operations
Senior Specialist, Vaccines Technology (Individual Contributor)
Responsibilities:
- Build robust processes to support consistent, reliable vaccine supply.
- Resolve and escalate technical issues impacting supply through IPT management processes.
- Own the Manufacturing Execution System (MES) batch record and facilitate changes as needed.
- Define and maintain Critical Process Parameters (CPP) so vaccines consistently meet critical quality attributes.
- Serve as technical subject matter expert during regulatory inspections.
- Generate/document process development and validation data to support licensure.
- Execute change management with scientific/technical justification.
- Investigate root cause and implement CAPAs for process-related compliance discrepancies.
- Manage technical startup activities to meet project deliverables/timelines.
- Recommend continuous improvement, productivity, and capital projects; partner with Operations/Quality to execute IPT projects.
Required Qualifications:
- Bachelor’s degree or higher in Engineering or Science (or related).
- 4+ years direct pharmaceutical packaging experience.
- 2+ years hands-on engineering/technical support in a cGMP biopharmaceutical/vaccine environment, including equipment validation/revalidation.
- Working knowledge of cGMPs and vaccine/pharma regulatory requirements.
- Experience supporting regulatory inspections (FDA).
- Technical writing experience (investigations, change requests, SOPs, batch records, protocols).
- Ability to work independently; strong interpersonal skills.
Preferred:
- Aseptic filling; qualified inspection processes; CIP/SIP; serialization/aggregation.
- Lean/continuous improvement, change execution tools, SAP/MES, CBER environment, data analysis/control limits setup.
Application:
Apply at https://jobs.merck.com/us/en (deadline listed on posting).
Responsibilities:
- Build robust processes to support consistent, reliable vaccine supply.
- Resolve and escalate technical issues impacting supply through IPT management processes.
- Own the Manufacturing Execution System (MES) batch record and facilitate changes as needed.
- Define and maintain Critical Process Parameters (CPP) so vaccines consistently meet critical quality attributes.
- Serve as technical subject matter expert during regulatory inspections.
- Generate/document process development and validation data to support licensure.
- Execute change management with scientific/technical justification.
- Investigate root cause and implement CAPAs for process-related compliance discrepancies.
- Manage technical startup activities to meet project deliverables/timelines.
- Recommend continuous improvement, productivity, and capital projects; partner with Operations/Quality to execute IPT projects.
Required Qualifications:
- Bachelor’s degree or higher in Engineering or Science (or related).
- 4+ years direct pharmaceutical packaging experience.
- 2+ years hands-on engineering/technical support in a cGMP biopharmaceutical/vaccine environment, including equipment validation/revalidation.
- Working knowledge of cGMPs and vaccine/pharma regulatory requirements.
- Experience supporting regulatory inspections (FDA).
- Technical writing experience (investigations, change requests, SOPs, batch records, protocols).
- Ability to work independently; strong interpersonal skills.
Preferred:
- Aseptic filling; qualified inspection processes; CIP/SIP; serialization/aggregation.
- Lean/continuous improvement, change execution tools, SAP/MES, CBER environment, data analysis/control limits setup.
Application:
Apply at https://jobs.merck.com/us/en (deadline listed on posting).