Senior Specialist, Vaccines Technology

Biopharma Careers; Kansas; Hybrid; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Sick days and family leave

Job summary

Merck seeks a Senior Specialist in Vaccines Technology to support startup, commissioning, tech transfer, validation, licensure, and ongoing technical support at the Wilson, NC vaccine facility. The role acts as the technical SME across CPPs, MBRs, and CAPAs, coordinating with QA, Operations, and IPT leadership.

The position requires a bachelor’s degree in engineering or science, 4+ years in pharma packaging, and hands-on experience in a cGMP vaccine environment, including regulatory interactions

Qualifications

• Bachelor degree in Engineering or Science; 4 years pharma packaging experience.
• 2+ years hands-on engineering/technical support in a cGMP biopharma/vaccine setting.
• Experience with regulatory inspections and investigations.
• Ability to work independently and as part of a team.
• Knowledge of cGMPs and regulatory expectations for vaccines.

Responsibilities

• Provide technical support to formulation, filling, inspection and packaging at the POD vaccine facility.
• Own MES batch records and manage changes to support business needs.
• Define CPPs and ensure vaccines meet quality attributes at the Wilson site.
• Act as SME during regulatory inspections and for licensure processes.
• Drive CAPAs, investigations, and corrective actions with robust documentation.
• Coordinate startup activities and ensure project deliverables and timelines.
• Collaborate with Operations, Quality and other groups to meet IPT goals.

Skills

cGMP knowledge

Problem-solving

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Science

Tools

SAP/MES

Job description

At our company, we aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and contribute to our mission of using leading-edge science to save and improve lives around the world.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

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 elevate 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 elevate 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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Employment Details

• 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

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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EEOC GINA Supplement

Salary & Benefits

The salary range for this role is $106,200.00 - $167,200.00

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .