Senior Specialist, Vaccines Technology

MSD • Wilson, NC

3d • Hybrid

About The Position

The Senior Specialist, Vaccines Technology Operations provides technical leadership or support for primary filling, inspection, and/or packaging operations at the vaccine manufacturing facility in Wilson, North Carolina. The role is an individual-contributor engineering position, with potential people-management responsibilities, on the Technical Operations team within a product POD Integrated Process Team (IPT). It supports commercial ramp-up of the facility and future routine operations, serving as the technical subject matter expert for validation and ongoing technical support in the assigned area.

The position applies technical expertise, independent judgment, and decision-making to establish robust processes that deliver consistent, reliable supply. It supports process compliance, validation, inspection readiness, change management, deviation investigation and corrective actions, and technical deliverables. The role also works cross-functionally to advance projects and continuous improvement. The position is based primarily onsite in Wilson, has a hybrid work arrangement, requires onsite work at least five days per week, and may require irregular hours to support multi-shift operations. Travel requirements are 10%.

Requirements

• Bachelor’s degree or higher in a science or engineering field; engineering is preferred.
• At least 5 years of relevant industry work experience.
• At least 2 years of experience providing validation and/or technical process support to pharmaceutical unit operations.
• Ability to work independently and as a team member.
• Strong interpersonal skills and ability to influence and support others through inclusion, feedback, and empowerment.
• Working knowledge of cGMPs and regulatory requirements applicable to the vaccine or pharmaceutical industry.
• Ability to work onsite at least 5 days per week.
• Ability to work irregular hours as needed to support multi-shift operations.
• Ability to work from ladders or work platforms.
• Experience supporting regulatory inspections, including FDA inspections.
• Technical writing experience with investigations, change requests, standard operating procedures, batch records, protocols, technical summaries, or similar documents.

Nice To Haves

• Experience with aseptic filling, aseptic process simulations, CIP/SIP systems, or single-use components.
• Experience leading vaccine manufacturing projects, investigations, or risk assessments.
• Experience with Change Execution Management tools.
• SAP and MES working knowledge.
• Experience working in a CBER-regulated environment.
• Demonstrated data analysis skills and experience analyzing process control limits using advanced Excel or statistical software packages such as Minitab or JMP.
• Experience in Continuous Improvement, Lean Manufacturing, Problem Solving, or Right First-Time methodologies.

Responsibilities

• Provide technical leadership or support for primary filling, inspection, and/or packaging operations.
• Apply technical expertise and independent judgment to build robust processes that support consistent and reliable supply.
• Resolve technical issues affecting supply and escalate them through daily, weekly, and monthly IPT management processes.
• Own Manufacturing Execution System batch record content and facilitate changes to meet business needs.
• Ensure assigned processes are robust and defined to consistently meet vaccine critical quality attributes.
• Serve as the technical subject matter expert during regulatory and internal inspections and interact with inspection officials during audits.
• Ensure process development, validation, qualification, and requalification data are generated and documented to support internal and regulatory inspections.
• Execute change management for the product POD IPT using Veeva Vault and provide scientific and technical justification for proposed changes.
• Author quality deviation reports, investigate issues, determine root causes, and implement corrective and preventive actions for process-related compliance discrepancies.
• Escalate compliance events through IPT management processes.
• Plan and manage validation activities so technical deliverables and timelines are defined in advance and achieved.
• Recommend continuous improvement, productivity, and capital projects for the IPT.
• Partner with Operations, Quality, Automation, Plant Engineering, and other groups to execute projects that support the IPT's strategic goals.
• Promote continuous improvement through standard work, problem visibility, waste minimization, variability reduction, and problem solving.
• Participate inclusively in cross-functional teams to advance projects and achieve deliverables.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior