Specialist, Engineering

Job Description

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, in accordance with applicable law.

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.

Under the supervision of a Senior Specialist or Associate Director, the specialist is responsible for providing technical manufacturing support in the field of engineering, maintenance and utilities (EMU).

Responsibilities

Accountability

• Provides day-to-day engineering assistance for assigned area which may include vaccine bulk manufacturing, filling, lyophilization, packaging, and/or mechanical support utilities including power, HVAC, steam, WFI and controlled temperature units

• Support and monitoring of equipment performance and maintenance, propose and develop equipment and facility improvements and troubleshoot process equipment to ensure reliable, compliant and efficient operations

• Actively ensures Good Manufacturing Practice (GMP) quality, safety, environmental, and operating cost goals are achieved

• On occasion, may provide supervisory coverage to ensure supply of a high quality product

Duties

• Works with Operations, other EM&U engineers, Technology, Maintenance Supervisors and mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with all GMP, safety and environmental regulations

• Champions the preventive and predictive maintenance program, reviews equipment history for reliability concerns, performs root cause analysis, and identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs | Develops maintenance and repair strategy for bi-annual shutdowns

• Assists/leads Operations, maintenance supervisors, mechanics, automation engineers, process engineers and Quality representatives in troubleshooting equipment problems as well as investigating manufacturing atypical events related to system failure or malfunction

• Serves as the project engineer and manager for small projects including scope development, design support, field execution and commissioning/qualification testing

• Identifies spare parts and stand-by equipment needed to assure maximum capacity and reliability

• Leads maintenance scheduling and planning processes

• Promotes positive safety culture and participates in Hazard and Operability (HAZOP) reviews and Safety inspections. Promotes open communications, inclusion and team work

• Authors Standard Operating Procedures or User Manuals and assists in training development for mechanics and supervisors

• Assists in the preparation of process studies, engineering standards, equipment utilization, and profit plan

• Explains and enforces all GMPs, safety, and environmental regulations

• Assist in audits, regulatory inspections and training in the area of responsibility

Education Minimum:

• B.S. in Engineering, Science OR four-year degree Engineering Technology or equivalent industry experience with a B.S. degree

Experience and Skills

Required

• Minimum three years of manufacturing or technical support group or equivalent

• Competencies Proficiency: Empowering Leadership | Flexibility, Motivation, Teamwork/Partnership | Problem-Solving | Communication | Computer Skills

• Knowledge in the application of engineering standards (i.e. American Society of Mechanical Engineers (ASME), Institute of Electrical and Electronics Engineers (IEEE), National Fire Prevention Association (NFPA), CFR 1910, National Institute of Standards and Technology (NIST), and/or American National Standards Institute (ANSI)

Preferred

• Knowledge of Current Good Manufacturing Process (cGMP) for pharmaceutical and/or vaccine manufacturing, Lean Six Sigma Methodology, Root Cause Analysis, Failure Mode Effects Analysis, knowledge in reliability engineering (including asset life cycle management). Computerized Management Maintenance Systems SAP), and Certified Maintenance and Reliability Professional (CMRP) certification desired.

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:R139081