Senior Specialist, Engineering

Job Description

If this position will be based in the US or Puerto Rico (not applicable to positions based outside of US or Puerto Rico): Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, 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.

The function of this position is to provide engineering technical support to the manufacture of liquid vaccines. The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management, and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus.

Responsibilities

• Serving as a single point of contact and SME for tech services for product franchise support for a product or family of products

• Leading cross-functional teams and acting as an individual contributor to drive validation activities change control and improvement projects across compliance, and strategic, including projects aimed at improving Right-First-Time performance, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times

• Authoring and approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes | Managing on-time implementation and close-out to meet project, production, and supply timelines

• Preparing source documentation for regulatory filings, supporting and serving as a lead SME during regulatory inspections related to process overviews, investigations, projects, and validation

• Authoring technical protocols, executing studies, and reporting results/conclusions in support of product tech transfers, process improvement projects, and deviation investigations | Utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs)

• Leading and completing all product Annual Review expectations including authoring Continued Process Verification Reports, including pulling data, generating charts, and statistically analyzing the data to identify whether preventative actions are required

• Approving new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)

• Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation, or process troubleshooting or to provide immediate responses to deviations and/or protocol exceptions

• Initiating and conducting validation assessments for proposed changes impacting the qualified processes

• Supporting team safety, environmental, and compliance objectives

• With in-depth product expertise, support 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 | Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.

• 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 | Executing projects and assigned studies in a right-first-time manner

• Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Mechanical Services, Automation, Technology), Quality, and Planning

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (MPS) tools, both in problem-solving and day-to-day operational activities

Education Requirement

• B.S. in Engineering Field

Experience and Skills

Required

• Engineering educational background

• Minimum five year post-Bachelor degree in vaccines in support of Production, Process Engineering, Technical Services, or related experience

• Product franchise tech services

• Tech services support activities for introduction or launch of new product

• Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred

• Validation documentation and execution

• Direct application of technical services in supporting the formulation and filling including manufacturing scale filling isolators and closed system processing

• Trackwise, MIDAS, SAP, MII, Delta V

• Change control documentation and execution

• Clean-in-Place and Sterilize-in-Place systems

• Regulatory agency interactions

• Ability to read Piping and Instrumentation Diagrams

• Support of deviation investigations and/or project work

• LSS/MPS certification/experience

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:

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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.

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:

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Flexible Work Arrangements:

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Requisition ID:R141841