Senior Engineer, Facility Operations; On-site

Position: Senior Engineer, Facility Operations (On-site)
## Senior Engineer, Facility Operations (On-site)
Apply remote type:
Not Applicable locations:
USA
- New Jersey
- Rahwaytime type:
Full time posted on:
Posted Todaytime left to apply:
End Date:
August 7, 2026 (14 days left to apply) job requisition :
R409210
** 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. 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…