Senior Specialist, Engineering

Job Description

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.

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.

Position Description

Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Sr. Specialist, Technical Services will support the Fermentation operation for the Recombivax HB and Gardasil franchises and is responsible for technical leadership and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, the Sr Specialist will work as an individual contributor as well as a team or project lead to lead work of others as required. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. Additional responsibilities include:

• Responsible for defining and leading projects.

• Specifically, will use standard project management approaches and assemble and lead teams in the execution of projects with responsibility for resourcing, charter development, project planning and tracking, risk management, and escalation.

• The incumbent will operate with a high degree of independence, assuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives.

• The incumbent will have interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management, and strong analytical, communication and interpersonal skills.

• Collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements.

• Determine project resource requirements and works with stakeholders to gain support needed from subject matter experts.

• Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings.

• Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation.

• Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale;

• Provide technical support to manufacturing for complex problems and issues

• Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

• Develop and assures consistent application of standardized work, engineering, and process tools.

• Problem-solving skills and a hands-on approach to problem-solving, with a bias toward going to see problems for oneself in the field

• May serve as a technical reviewer/approver for process changes.

• Support process improvement projects, complex manufacturing investigations, digital and data integrity initiatives for the project

• Support regulatory inspections based requests

​Education Minimum Requirement:

• Bachelor's Degree in Engineering or Science

Required Experience and Skills:

• Minimum 5 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 1 years).

• Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role

• Minimum of 3 yrs project management experience with executing projects in qualified production facilities

• Strong Understanding of Change Control. Minimum of 2 years of experience in Change Control.

Preferred Experience and Skills:

• Advanced degree (M.S., Ph.D.) in science or engineering

• Ability to maintain strong working relationships with technical, quality and operations leaders

• Experience with equipment and automation troubleshooting.

• Experience in Process monitoring and trending tools

• DeltaV, GCM experience

• Regulatory inspection presentation experience with external regulatory authority representatives.

• Experience with one or more of the following areas: Fermentation | Purification | Validation | formulation and filling processes.

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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:

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R154572