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

HireLifeScience; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) plan

Paid holidays

Vacation

Sick leave

Job summary

Merck in Rahway, NJ, seeks an experienced engineer to operate and supervise a Biologics GMP facility, focusing on utilities and process equipment for drug substance manufacturing. The role supports startup activities, equipment qualification, and ongoing calibration and maintenance to ensure compliance and readiness for clinical trial supply.

You will mentor junior staff, train teams in safety, compliance, and technical SOPs, and collaborate across the network to promote operational consistency

Qualifications

• 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.

Responsibilities

• Act as an SME for 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.
• Provide timely performance feedback and foster culture of trust for open dialogue.
• Coach Junior team members in development planning for soft and technical skills.

Skills

Building Capability

Capital Project Management

Competency Management

Data Analysis

Deviation Management

Employee Training

Equipment Installations

Equipment Maintenance

Equipment Management

GMP

Microsoft Project

Operation Maintenance

Procedure Writing

Process Hazard Analysis

Root Cause Analysis

Education

Bachelor's degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline

Master's degree with minimum 3 years of relevant experience

Tools

CMMS

CCMS

DeltaV

MES

SAP

Veeva Quality Docs

Job description

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Company's biologics pipeline. We work closely with colleagues in Discovery, Pre-clinical, and Early Development to rapidly develop processes for different biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development, and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

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.

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)

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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Learn more about your rights, including under California, Colorado and other US State Acts

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

The salary range for this role is $117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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.

Requisition ID:

R419999