Merck & Co, Inc

Senior Specialist, Vaccines Technology

Merck & Co, Inc • $106K — $167K *
Wilson, NC 27893In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in Engineering, Science, or related fields.
  • Minimum of four years in pharmaceutical packaging experience.
  • At least two years of technical support in a cGMP biopharmaceutical/vaccine manufacturing environment.
  • Strong interpersonal skills with an ability to influence others.
  • Good knowledge of cGMPs and regulatory requirements for vaccines and pharmaceuticals.
  • Experience in supporting FDA regulatory inspections.
  • Technical writing expertise in investigations and protocols.

Responsibilities

  • Utilize technical expertise to build robust manufacturing processes.
  • Resolve and escalate technical issues affecting supply.
  • Provide ownership for Manufacturing Execution System (MES) batch records.
  • Ensure vaccines meet critical quality attributes through defined CPPs.
  • Act as the technical subject matter expert during regulatory inspections.
  • Generate and document process validation data for regulatory compliance.
  • Manage startup activities to meet project deliverables and timelines.

Benefits

  • Hybrid flexible work arrangements.
  • Ongoing professional development opportunities.
  • Collaborative work with cross-functional teams.
  • Exposure to advanced technology in vaccine manufacturing.
  • Opportunities for continuous improvement initiatives.
Full Job Description
Job Description

The Senior Specialist, Vaccines Technology position is responsible for providing technical support to formulation, primary filling, inspection, and/or packaging operations within our product's Points of Dispensing (POD) vaccine manufacturing facility at the Wilson, North Carolina site. This position will be an individual contributor and member of the Technical Team within the Vaccines Integrated Process Team (IPT).

This will be an engineering role focused on startup of the POD vaccine manufacturing facility as well as providing future routine operational support. This role will act as the technical subject matter expert for all aspects of commissioning, tech transfer, start up, validation, licensure, and ongoing technical support for their area of assignment.

Responsibilities
  • Utilize technical expertise, experience, independent judgment, and decision-making to build robust processes that support consistent and reliable supply.
  • Resolve and escalate technical issues impacting supply within the daily, weekly, and monthly IPT management processes.
  • Provide ownership for Manufacturing Execution System (MES) batch record and facilitate changes as needed to support business needs.
  • Ensure that assigned processes are developed in a robust manner and Critical Process Parameters (CPP) defined such that vaccines filled at the Wilson site consistently meets critical quality attributes.
  • Act as technical subject matter expert during regulatory inspections for area of assignment.
  • Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies.
  • Execute change management for the PT and provide scientific/technical justification for proposed changes to support business needs.
  • Investigate, determine root cause, and implement robust Corrective Action and Preventive Action (CAPAs) for any process-related compliance discrepancies noted during day-to-day activities and/or audits and escalate as per IPT management processes.
  • Ensure that technical startup activities for area of assignment are managed such that project deliverables and timelines are well defined in advance and met.
  • Recommend continuous improvement, productivity, and capital projects for the IPT.
  • Partner with Operations, Quality, and other groups to execute projects that support the strategic goals of the IPT.
  • Maintain a culture of continuous improvement and MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem-solving.
  • Actively participate on cross-functional teams in an inclusive manner to advance project goals and achieve deliverables.


Qualifications

Required
  • 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 of 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, standard operating procedures, batch records, protocols, etc.


Preferred
  • Aseptic filling, qualified inspection processes, Cleaning-in-Place (CIP) and Sterilization-in-place (SIP) systems, pharmaceutical packaging and serialization/aggregation.
  • Leading manufacturing/packaging projects and investigations.
  • Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies.
  • Familiarity with Change Execution Management tools.
  • SAP/MES working knowledge.
  • Working in a Center for Biologics Evaluation and Research (CBER) regulated environment.
  • Demonstrated data analysis skills and experience setting up process control limits (advanced Excel, statistical software packages (Minitab), etc.).


Required Skills:
Business Management Tools, Contractor Oversight, Customer Service, Detail-Oriented, Driving Continuous Improvement, Engineering Design, Engineering Standards, Facility Management, OSHA Regulations, Process Engineering, Standard Operating Procedure (SOP) Writing, Technical Problem-Solving, Utilities Management, Vendor Management

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
09/10/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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