Senior Specialist, Vaccines Technology

Merck; Wilson (NC); On-site; USD 106,000 - 167,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Holidays

Vacation & Sick Days

Job summary

Merck in North Carolina seeks an experienced Senior Specialist, Vaccines Technology to lead startup and ongoing technical support for the POD vaccine manufacturing facility at the Wilson site. You will serve as a technical SME for commissioning, tech transfer, validation, licensure, and ongoing support, collaborating across IPT and Operations.

The role requires a strong background in pharma packaging, cGMP, and regulatory inspections, with capability to work irregular hours and manage complex

Qualifications

• Bachelor degree or higher in Engineering or Science.
• Minimum of four (4) years of direct pharmaceutical packaging experience.
• Minimum of two (2) years of hands-on engineering or technical support in a cGMP biopharmaceutical/vaccine environment.
• Demonstrated ability to work independently as a team member.
• Strong interpersonal skills with ability to influence and support others.
• Working knowledge of cGMPs and regulatory requirements in vaccine/pharma.
• Willing to work irregular hours to support multi-shift operation.
• Experience supporting regulatory inspections including FDA.
• Technical writing experience with investigations, change requests, SOPs, batch records, protocols.

Responsibilities

• Utilize technical expertise to build robust processes that support reliable supply.
• Resolve technical issues impacting supply in IPT processes.
• Own MES batch records and facilitate changes.
• Ensure CPPs defined for vaccines filled at Wilson site.
• Act as SME during regulatory inspections for area of assignment.
• Ensure development and validation data support licensure and regulatory interactions.
• Execute change management with scientific justification for changes.
• Investigate and implement CAPAs for process discrepancies.
• Ensure startup activities are well defined and met.

Skills

Detail-Oriented

Technical Problem-Solving

Process Engineering

Facility Management

Engineering Standards

OSHA Regulations

Vendor Management

Regulatory Inspections

Education

Bachelor degree or higher in Engineering or Science

Tools

SAP/MES

Job description

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.

Required

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 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.

Requirements

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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement 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

Salary

The salary range for this role is $106,200.00 - $167,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

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.