Vaccines Technology Senior Specialist
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.
Summary, Focus and Purpose
The Vaccines Technology Senior Specialist position is responsible for providing technical support to formulation, primary filling, inspection, and/or packaging operations within the Point 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 and will be 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.
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
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 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
Actively participate on cross-functional teams in an inclusive manner to advance projects goals and achieve deliverables
Bachelor's degree or higher in Engineering or Science, or related areas of study
Required Experience | Knowledge | Skills
Minimum five (5) years of relevant industry work experience
Demonstrated ability to work independently as team member
Demonstrated strong interpersonal skills with 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 Experience | Knowledge | Skills
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.)
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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., Rahway, 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.
Residents of Colorado
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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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.
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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.
Residents of Colorado:
Click here to request this role’s pay range.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Flexible Work Arrangements:Not Specified
Shift:1st - Day
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Number of Openings:1