Associate Specialist, Engineering ( MERCUSR171837ENUS)
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!
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 function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role is focused on technical services support with primary focus in the areas of customer complaints. The role also encompasses technical services support with primary focus in the areas of deviation management, validation and product franchise support. Specific assignments maybe focused in one area or span across multiple areas of focus.
Performing customer complaint investigations, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations
Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery.
Performing deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment and where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times
Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation
Authoring updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)
Supporting team safety, environmental and compliance objectives
Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Maintenance, Automation, Technology, Quality, and Planning)
Executing projects and assigned studies in a right-first-time manner
Actively using and championing the use of Lean Six Sigma (LSS) and Company Production System (CPS) tools, both in problem solving and day-to-day operational activities
Education Minimum Requirement:
B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree
Required Experience and Skills:
Engineering or science educational background
Demonstrated ability to work both independently and as a part of a team
Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills
Preferred Experience and Skills:
6+ months of relevant work experience
Support of vaccine operations or technical services support
Experience with troubleshooting biotech equipment and closed system processing
Experience with Trackwise, MIDAS, SAP
Ability to read Piping and Instrumentation Diagrams
Support of deviation investigations and/or project work
LSS/MPS certification / experience
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
Secondary Language(s) Job Description
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:
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., 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