Sr. Specialist, Engineering

Job Description

Lead the company’s quality risk management assessments related to incoming materials and provide technical support to the pharmaceutical company’s manufacturing area for complex problems and issues. Lead projects related to introduction of raw materials into a good manufacturing practice (GMP) environment and qualification of new supply chains. Serve as subject matter expert (SME) performing impact assessment for incoming materials related changes. Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. Develop and assure consistent application of standardized work, engineering, and process tools. Provide data analysis of the change controls including the creation/ updating of trending reports. Lead and/or execute process improvement projects and complex changes. Resolve issues by examining and understanding the issues from diverse perspectives (safety, compliance, automation, equipment, process, and people). Manage change controls from notification through closure meeting timelines to ensure key compliance and customer due dates are met; escalate any potential delays and develop remediation plans when possible. Serve as liaison between site and global technical operations and site lab services. Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, change control, and validation. Lead and/or work as a team member on vendor change controls, process improvement, and/or projects. Participate in regulatory inspection activities for the facility. Provide leadership and manage efforts to support supply chain duality.

Must have a Master’s degree in Pharmacy or Regulatory Affairs or closely related field plus three (3) years experience in GMP manufacturing and/or technical support of GMP manufacturing operations or a Bachelor’s degree in Pharmacy or Regulatory Affairs or closely related field plus five (5) years experience in GMP manufacturing and/or technical support of GMP manufacturing operations. Must have experience in biologics, vaccine or bulk sterile manufacturing facilities and performing change controls (authoring) and project management in regulated industrial setting. Experience with introduction of raw materials into a GMP environment and qualification of new supply chains is required. Must have experience in skills: SAP, Trackwise, Tracelink. Must have experience in audits/inspections and managing audit/inspection requests. Must have strong written and verbal communication skills, analytical and decision-making ability. Telecommuting permitted. 40 hours per week: M-F-9am-5pm. Must have proof of legal authority to work in the U.S.

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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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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.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

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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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R239851