Merck & Co, Inc

Senior Specialist, Engineering (Onsite)

Merck & Co, Inc$117K — $184K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related field with 5+ years of relevant experience.
  • Subject Matter Expertise in sterile processing equipment like automated filling lines, lyophilizers, and autoclaves.
  • Knowledge of automation systems (PLC, DCS, MES) and Drug Product aseptic processing techniques.
  • Experience leading quality deviation investigations and change management.
  • Familiarity with GMP and Safety compliance regulations in the US and EU.
  • Ability to prepare Standard Operating Procedures (SOP) and GXP documents.
  • Strong technical aptitude and critical thinking for troubleshooting and resolving production issues.
  • Lean Six Sigma Green Belt certification.

Responsibilities

  • Support routine operations through troubleshooting and resolving production equipment issues.
  • Establish new processes and implement continuous improvement projects.
  • Collaborate with cross-functional teams to ensure compliant and efficient operations.
  • Prepare and maintain Standard Operating Procedures for equipment processes.
  • Lead project initiatives from planning to execution, managing scope and stakeholder expectations.
  • Deliver training and guidance to team members on best practices and procedures.
  • Provide occasional second shift and weekend support as needed.

Benefits

  • Comprehensive health benefits package.
  • Professional development opportunities including training and certifications.
  • Collaborative work environment with cross-functional teams.
  • On-site work fostering direct interaction with production operations.
  • Potential for domestic or international relocation assistance.
Full Job Description
Job Description

The FLEx organization is seeking a highly motivated individual to serve the role of Senior Specialist, Technical Operations Engineer, reporting to the Technical Operations Engineering Lead. The successful candidate will support routine operations through timely troubleshooting and resolution of production equipment issues, establishment of new processes and implementation of continuous improvement projects with goals to reduce operation cycle time, errors, and costs. This individual will collaborate closely with the Production, New Product Introduction, Facilities, Equipment, Automation and Quality teams to ensure compliant, right first-time execution and timely delivery of business goals. The role is on-site, based in Rahway, NJ and will support our first shift operations. To ensure continuity of operations, occasional second-shift coverage may be required to support the second-shift team during periods of absence. Occasional weekend support may also be necessary based on business and operational needs.

Education Minimum Requirements:
  • BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering or related engineering field with a minimum of 5 years of relevant experience.


Required Experience and Skills:
  • Subject Matter Expertise in various sterile processing equipment such as automated filling lines, lyophilizers, autoclaves, part washers, isolators and etc.
  • Knowledge of automation systems such as PLC, DCS, and MES.
  • Knowledge of Drug Product aseptic processing techniques.
  • Experience in leading and supporting quality deviation investigations and change management.
  • Familiarity with United States and European Union GMP and Safety compliance regulations.
  • Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
  • Strong technical aptitude and critical thinking skills to effectively troubleshoot and resolve issues on the production floor.
  • Demonstrated project management experience leading cross-functional initiatives from planning through execution, with a proven ability to manage scope, timelines, risks, and stakeholder expectations.
  • Possess and leverages strong working knowledge of theories, practices, and procedures to train others efficiently. Applies knowledge to improve processes.
  • Familiarity with common Drug Product processing unit operations such as mixing, filtration, temperature control and etc.
  • Lean Six Sigma Green Belt certification.
  • Effective interpersonal and communication skills, both verbal and written.
  • Excellent organizational skills to multi-task.
  • Desire and willingness to learn, contribute and lead.
  • Track-record of independent problem-solving.


Preferred Experience and Skills:
  • Experience providing technical mentorship to engineers and cross-functional team members, including guidance on problem-solving, project execution, and professional development.
  • Experience with Commissioning, Qualification and Validation of equipment.
  • Understanding of ISA88 and ISA95 principles.
  • Knowledge of Investigational drug regulatory requirements.
  • Understanding of Clinical Supply Chain Operations.
  • Lean Six Sigma Black Belt certification.


#eligibleforERP

#PSCS

FLEx2026

Sterile2026

Required Skills:
Analytical Testing, Change Management, Chemical Engineering, Chemical Technology, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Process Hazard Analysis (PHA), Process Improvements, Process Optimization, Root Cause Analysis (RCA), Six Sigma, Strategic Thinking, Technical Problem-Solving

Preferred Skills:

Employee Status:
Regular

Relocation:
Domestic/International

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
07/21/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ

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