Merck & Co, Inc

Senior Engineer, Facility & Utilities Operations (On-site)

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

Qualifications

  • Bachelor's or Master's degree in relevant scientific field with 3-5 years of experience in GMP environments.
  • 3+ years of experience with clean utilities systems and biologics manufacturing equipment.
  • Familiarity with HVAC systems and temperature control units.
  • Proficient in Computerized Maintenance Management Systems (CMMS) and Computerized Calibration Management Systems (CCMS).
  • Strong understanding of GMP regulations and quality systems.

Responsibilities

  • Act as a subject matter expert for facility and utilities equipment operations.
  • Support maintenance and calibration of process equipment and utilities.
  • Ensure 24/7 operational support for GMP activities as part of the engineering team.
  • Assist in start-up activities, including equipment qualification and staff training.
  • Manage vendor relationships during maintenance and calibration tasks.
  • Coach junior team members in technical and compliance skills.
  • Drive compliance with cGMP and promote a strong safety culture.

Benefits

  • Opportunity to work in a state-of-the-art facility with cutting-edge technology.
  • Engagement in a dynamic, multi-product operational environment.
  • Chance to influence and shape the operational readiness of a new GMP facility.
  • Collaboration with a diverse team across the organization to share best practices.
Full Job Description
Job Description

This role will support the Next Generation Biologics (NGB) facility, which will be a premier, state-of-the-art facility, that is a key part of our Chemistry, Manufacturing, and Controls (CMC) hub at our site headquarters in Rahway, NJ. This facility will be fully online in the next few years, both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites, which can adjust as the clinical pipeline demands change. It can meet all historic, currently existing, and cutting-edge biologics program demands from supporting development to pilot scale, small and large scale potent material handling, and the ability to integrate new technologies and cell-line platforms.

The Sr. Engineer, Facility Operations, will support the NGB Operations Leadership team, reporting to the Associate Director of Facility & Utilities Engineering Lead.

Job Responsibilities:

  • Act as an SME for the operation of innovative facility & utilities equipment, preparing/reviewing user requirements.
  • Support process & facilities equipment, and utilities (clean and grey) maintenance and calibration.
  • Active member of Facility & Utilities Engineering team to ensure 24/7/ 365 building support for critical GMP operations.
  • Support start-up activities including equipment qualification, training curricula, staff training, and CMMS implementation.
  • Support operational readiness activities for launch of the new GMP facility.
  • Manage vendor and contractors during maintenance and calibration of process equipment process.
  • Provide timely performance feedback and foster culture of trust for open dialogue.
  • Coach Junior team members in the development planning process for soft and technical skills.
  • Training skills: Ability to train technicians in technical, compliance, safety, and environmental procedures; ability to write SOPs and technical documents and present to peers and senior management.
  • Drive cGMP and EHS compliance and promote a strong safety culture.
  • Maintain a strong floor presence during GMP operations and support critical tasks as needed.
  • Troubleshoot technical and equipment issues and make timely operational decisions.
  • Initiate deviations, perform initial impact assessments, and support investigations.
  • Author, revise, and approve SOPs, work instructions, and memos.
  • Provide off-hours, weekend, holiday, and on-call support as needed.
  • Oversee Facility & Utilities planning and associated activities.
  • Collaborate across the network to share best practices and promote operational consistency.

Education:

  • Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with minimum of 5 years relevant experience, or a Master's degree with minimum 3 years of relevant experience.


Experience & Skills:

  • 3+ years of experience in a GMP-regulated clean utilities systems, biologics drug substance manufacturing equipment.
  • Familiar with HVAC, cold rooms and temperature control units (TCU).
  • Working knowledge of Computerized Maintenance Management System (CMMS) & Computerized Calibration Management System (CCMS).
  • Strong understanding of GMP manufacturing environments, including upstream and downstream processing equipment.
  • Working knowledge of cGMP, Quality Systems, and EHS requirements.
  • Ability to train employees in technical, compliance, safety, and environmental procedures.
  • Experience writing SOPs and technical documents.
  • Working knowledge of DeltaV.
  • Strong troubleshooting, decision-making, and attention to detail skills.
  • Demonstrated initiative and ability to work effectively in a fast-paced environment.
  • Ability to use tools such as Microsoft Office, and project management software.
  • Ability to lift up to 25 lbs, if required.


Preferred Experience and Skills:

  • Experience with operationalization of GMP operations and/or large facility builds or renovations.
  • Managing execution of capital projects.
  • Experience with Veeva Quality Docs.
  • Working knowledge of MES and SAP.
  • Lean manufacturing and root cause analysis experience.
  • Background in process engineering and providing support for a Biologics facility focused on upstream/downstream, or biologics/vaccine manufacturing operations
  • Demonstrated ability to drive improvements and inspire others.
  • Strong organizational, planning, communication, and presentation skills.
  • Continuous improvement mindset and willingness to challenge the status quo.


#eligibleforERP

#PRD

Required Skills:
Building Capability, Capital Project Management, Competency Management, Data Analysis, Deviation Management, Employee Training, Equipment Installations, Equipment Maintenance, Equipment Management, Good Manufacturing Practices (GMP), Microsoft Project, Operation Maintenance, Procedure Writing, Process Hazard Analysis (PHA), Root Cause Analysis (RCA)

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/8/2026
*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.

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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.

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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.

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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.

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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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