Specialist - Engineering

Job Description

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.

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 deviation management, customer complaints, validation and product franchise. The primary focus of assignments will be in validation and product franchise support

Position Responsibilities

• Author, review, and approve technical protocols, including validation

• Coordinate, organize, and execute validation studies

• Provide product franchise support including proactive process monitoring, product data management, and technical collaboration with external manufacturing, and other above site groups

• Support regulatory inspections including preparing source documentation, requests related to process overviews, investigations, projects and validation.

• Provide 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 potential deviations.

• Complete projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times

• Execute projects and assigned studies in a right-first-time manner.

• Author updates to Master Batch Records (production process descriptions) and Standard Operating Procedures.

• Support team safety, environmental, and compliance objectives.

• Collaborate effectively with the area Managers, Operators/Technicians, support groups (Maintenance, Automation, Technical Operations), Quality, and Planning.

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

Education

• B.S. or B.A. in Mechanical or Chemical Engineering degree or other science degree

Required Experience and Skills

• Engineering or science educational background

• Minimum of 2-year post-Bachelor’s degree experience in support of Production, Process Engineering, Validation, Technical Services or related experience

• Minimum of 1-year experience in Deviation Management

• 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

• Ability to read Piping and Instrumentation Diagrams

Preferred Experience and Skills

• Hands-on technical services experience in supporting formulation and filling, including manufacturing-scale filling isolators and closed system processing

• Experience with troubleshooting biotech equipment and closed system processing.

• Experience with MIDAS, SAP, PI, DeltaV, ProCal, TrackWise

• Knowledge of CIP, SIP, and VHP processes

• Support of deviation investigations and/or project work

• Experience with regulatory agency interactions

• LSS/MPS certification/experience

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

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., 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):

Number of Openings:

Requisition ID:R182409