Vaccine Process Engineer: Startup & Validation

EyeBio; Wilson (NC); Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck in Wilson, NC is seeking a Senior Specialist, Vaccines Technology to start up a POD vaccine manufacturing facility and provide ongoing technical support. You will act as SME for commissioning, tech transfer, validation, and licensure, while coordinating with IPT and other groups to meet project timelines.

The role requires 4+ years in pharmaceutical packaging/engineering, cGMP experience, and ability to work irregular hours.

Qualifications

• Bachelor’s degree or higher in Engineering or Science, or related areas.
• Experience in a cGMP biopharmaceutical/vaccine manufacturing environment.
• Independent team contributor with strong interpersonal skills.
• Familiar with cGMPs and regulatory requirements.
• Willing to work irregular hours for multi‑shift operation.
• Experience supporting regulatory inspections (FDA).
• Technical writing for investigations, change requests, SOPs, batch records.

Responsibilities

• Provide technical startup and ongoing support for vaccine manufacturing area.
• Own MES batch records and coordinate changes to meet business needs.
• Define CPPs to ensure vaccine quality attributes at the Wilson site.
• Serve as SME during regulatory inspections for the area.
• Generate and document development/validation data for licensure.
• Lead change management with scientific justification.
• Investigate, root-cause, and implement CAPAs for deviations.
• Ensure project deliverables and timelines are defined and met.
• Drive continuous improvement and capital projects with IPT.
• Collaborate with Operations, Quality and other groups.

Skills

Business Management Tools

Contractor Oversight

Customer Service

Detail‑Oriented

Driving Continuous Improvement

Engineering Design

Engineering Standards

Facility Management

OSHA Regulations

Process Engineering

SOP Writing

Technical Problem‑Solving

Utilities Management

Vendor Management

Education

Bachelor's degree in Engineering or Science

Tools

SAP

MES (Manufacturing Execution System)

Job description

Merck in Wilson, NC is seeking a Senior Specialist, Vaccines Technology to start up a POD vaccine manufacturing facility and provide ongoing technical support. You will act as SME for commissioning, tech transfer, validation, and licensure, while coordinating with IPT and other groups to meet project timelines.

The role requires 4+ years in pharmaceutical packaging/engineering, cGMP experience, and ability to work irregular hours.