Vaccine Process Engineer: Startup & Tech Transfer

Merck; Wilson (NC); On-site; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Holidays

Vacation & Sick Days

Job summary

Merck in North Carolina seeks an experienced Senior Specialist, Vaccines Technology to lead startup and ongoing technical support for the POD vaccine manufacturing facility at the Wilson site. You will serve as a technical SME for commissioning, tech transfer, validation, licensure, and ongoing support, collaborating across IPT and Operations.

The role requires a strong background in pharma packaging, cGMP, and regulatory inspections, with capability to work irregular hours and manage complex

Qualifications

• Bachelor degree or higher in Engineering or Science.
• Minimum of four (4) years of direct pharmaceutical packaging experience.
• Minimum of two (2) years of hands-on engineering or technical support in a cGMP biopharmaceutical/vaccine environment.
• Demonstrated ability to work independently as a team member.
• Strong interpersonal skills with ability to influence and support others.
• Working knowledge of cGMPs and regulatory requirements in vaccine/pharma.
• Willing to work irregular hours to support multi-shift operation.
• Experience supporting regulatory inspections including FDA.
• Technical writing experience with investigations, change requests, SOPs, batch records, protocols.

Responsibilities

• Utilize technical expertise to build robust processes that support reliable supply.
• Resolve technical issues impacting supply in IPT processes.
• Own MES batch records and facilitate changes.
• Ensure CPPs defined for vaccines filled at Wilson site.
• Act as SME during regulatory inspections for area of assignment.
• Ensure development and validation data support licensure and regulatory interactions.
• Execute change management with scientific justification for changes.
• Investigate and implement CAPAs for process discrepancies.
• Ensure startup activities are well defined and met.

Skills

Detail-Oriented

Technical Problem-Solving

Process Engineering

Facility Management

Engineering Standards

OSHA Regulations

Vendor Management

Regulatory Inspections

Education

Bachelor degree or higher in Engineering or Science

Tools

SAP/MES

Job description

Merck in North Carolina seeks an experienced Senior Specialist, Vaccines Technology to lead startup and ongoing technical support for the POD vaccine manufacturing facility at the Wilson site. You will serve as a technical SME for commissioning, tech transfer, validation, licensure, and ongoing support, collaborating across IPT and Operations.

The role requires a strong background in pharma packaging, cGMP, and regulatory inspections, with capability to work irregular hours and manage complex