Job Description

The Associate Specialist, Vaccines Technology position is responsible for providing technical support to formulation, primary filling, inspection, and/or packaging operations within the Pod Vaccine Manufacturing Facility at the Wilson, NC 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

Delivery

• 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 MES batch record and facilitate changes as needed to support business needs

Compliance

• Ensure that assigned manufacturing or packaging processes are developed in a robust manner and CPPs defined such that vaccines filled at the Wilson site consistently meet critical quality attributes
• Ensure that process development and validation data is generated and documented in a manner that supports successful licensure and positive interactions with regulatory agencies
• Support change management activities for the Vaccines IPT(Trackwise GCM) and provide scientific/technical justification for proposed changes to support business needs
• Investigate, determine root cause, and implement robust CAPAs for any process related compliance discrepancies noted during day to day activities and/or audits | Escalate as per IPT management processes

Cost

• 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

Continuous Improvement

• Execute projects that support the strategic goals of the Vaccines IPT
• Maintain a culture of continuous improvement and MPS focused on standard work, making problems visible, minimizing waste, reducing process variability, and problem solving

Education Requirement

• Bachelor degree or higher in Science or Engineering field (Engineering preferred)

Experience and Skills

Required

• 0-2 years of relevant pharmaceutical industry
• Demonstrated ability to work independently as team member
• Demonstrated interpersonal skills with ability to influence and support others through a culture of inclusion, feedback, and empowerment
• Willing to work irregular hours to support multi-shift operation on an as needed basis
• Technical writing skills

Preferred

• Basic knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
• Authoring investigations, change requests, standard operating procedures, batch records, protocols, etc.
• Aseptic filling, qualified inspection processes, CIP/SIP systems, pharmaceutical packaging and serialization/aggregation
• Continuous Improvement, Lean Manufacturing, Problem Solving, and/or Right First-Time methodologies
• SAP/MES basic knowledge
• Working in a regulated environment (FDA, etc.)
• Demonstrated data analysis skills and experience setting up process control limits (advanced Excel, statistical software packages (Minitab), etc.)
• Intern experience supporting pharmaceutical unit operations

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

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

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Number of Openings:

1

Requisition ID:R127918