Vaccine Technology Engineer - Startup & Validation

Merck & Co.

Wilson (NC)

Hybrid

USD 106,000 - 167,000

Full time

7 days ago

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Benefits offered by this job

Hybrid work arrangement

Travel 10%

Job summary

Merck & Co. in Wilson, NC, seeks a Senior Specialist to support the POD vaccine manufacturing startup and ongoing operations.

You will serve as a technical SME for commissioning, tech transfer, start‑up, and validation within the Vaccines IPT, coordinating with Operations and Quality to meet timelines and quality standards. The role requires 4+ years in pharmaceutical packaging and 2+ years in engineering or technical support in a cGMP vaccine environment, with flexibility for irregular hours

Qualifications

Bachelor degree or higher in Engineering or Science, or related areas of study.
Minimum of four (4) years of direct pharmaceutical packaging experience.
Minimum of two (2) years of hands‑on engineering or technical support experience in a cGMP biopharmaceutical/vaccine manufacturing environment, including direct participation in equipment validation/revalidation.
Demonstrated ability to work independently as a team member.
Demonstrated strong interpersonal skills with the ability to influence and support others through a culture of inclusion, feedback, and empowerment.
Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements as they apply to the vaccine/pharmaceutical industry.
Willing to work irregular hours to support multi‑shift operation on an as‑needed basis.
Experience supporting regulatory inspections including Federal Drug Administration (FDA).
Technical writing experience with investigations, change requests, SOPs, batch records, protocols, etc.

Responsibilities

Utilize technical expertise, independent judgment, and decision‑making to build robust processes that support consistent and reliable supply.
Resolve and elevate technical issues impacting supply within IPT management processes.
Provide ownership for MES batch records and facilitate changes to support business needs.
Ensure processes are robust and CPPs defined so vaccines meet critical quality attributes.
Act as technical SME during regulatory inspections for area of assignment.
Ensure data supports licensure and regulatory interactions.
Execute change management for the PT with technical justification.
Investigate, determine root cause, and implement CAPAs for compliance discrepancies.
Lead startup activities and ensure project deliverables and timelines are met.
Recommend continuous improvement and capital projects for the IPT.
Collaborate with Operations, Quality, and other groups to support strategic goals.
Maintain a culture of continuous improvement and standard work.