Senior Specialist, Engineering

Job Description

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.

Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Senior Specialist, Technical Services | Process Engineering in the Manufacturing Division End-to-End 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 and 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.

Responsibilities

• Defining and leading projects

• 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

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

• Develop and implement 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 an involved approach to problem-solving, with a bias toward going to see problems for oneself in the field

• 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 Requirement

• Bachelor degree in Engineering or Science

Experience and Skills

Required

• Minimum five years post-bachelor 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)

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

• Minimum three years project management with project implementation in qualified production facilities

• Strong understanding of Change Control

• Minimum two years of experience in Change Control

Preferred

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

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

• Equipment and automation troubleshooting

• Process monitoring and trending tools

• DeltaV, GCM

• Regulatory inspection presentation with external regulatory authority representatives

• Fermentation | Purification | Validation | formulation and filling processes

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:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

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:R127451