Specialist Engineering; Onsite

Specialist Engineering (Onsite)
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Apply:
Not Applicable:
USA
- New Jersey
- Rahway:
Full time:
Posted Today:
End Date:
November 4, 2026 (6 days left to apply):
R424343
** Job Description
** This Engineer position provides on-site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). Off-shift (2nd shift), Monday through Friday, is required to meet operational needs.  The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage (OSD) products, including process development, scale-up, launch and transfer to the supply network, and process optimization for commercial products.  

The primary responsibility of this role is to maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements while applying Reliability Maintenance best practices to support timely availability of clinical and development batches. This includes troubleshooting equipment, partnering with GES, Facilities Management, OEMs, and vendors, and providing engineering and compliance support for non-sterile process equipment and utilities.  

The role operates with minimal supervision and serves as a technical and compliance resource during second shift operations. Responsibilities include supporting equipment validation from commissioning through decommissioning, managing changes and periodic reviews, investigating deviations, issuing Quality Notifications, identifying root causes and CAPAs, maintaining GMP documentation, supporting clinical operations, managing purchase orders and capital requests, coordinating installation and commissioning of new equipment, and supporting regulatory interactions as an SME when needed.

** Education
* * Bachelor’s degree in engineering plus a minimum of 2 years of related experience supporting pharmaceutical manufacturing.  
** Required Experience and Skills
*** Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
* Familiarity with Computerized Maintenance and Management Systems (CMMS).
* Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.
* Effective organizational skills.
* Effective communication and technical writing skills.
* Strong computer skills  
** Preferred

Experience and Skills:

*** Familiarity with Oral Solid Dosage (OSD) Drug Product manufacturing equipment and process.
* Troubleshooting ability (mechanical/electrical/automation)
* Maintenance & Engineering techniques and management and Capital Project management.
* Independent problem- solving.
* SAP Plant Maintenance (Gatekeeping and Work Order Prioritization)
* eVal/Kneat  - Paperless electronic validation system
* Experience with Pro Cal as a…