Specialist Engineering (Onsite)
About The Position
This Engineer position provides on-site engineering support for the Rahway, New Jersey FLEx (Formulation, Laboratory & Experimentation) center, supporting non-sterile operations within Research Labs Pharmaceutical Sciences and the Pharmaceutical Operations Engineering group. The role requires working off-shift (second shift), Monday through Friday, to meet operational needs. The FLEx facility supports formulation and filling activities for clinical, stability, and developmental supplies for Oral Solid Dosage products. Activities include process development, scale-up, launch and transfer to the supply network, and process optimization for commercial products. The primary responsibility is to maintain facility, utilities, and manufacturing equipment in compliance with GMP and safety requirements, applying Reliability Maintenance best practices to ensure timely availability of clinical and development batches. The position operates with minimal supervision and serves as a technical and compliance resource during second-shift operations. It provides engineering and compliance support for non-sterile process equipment and utilities, working with GES, Facilities Management, OEMs, and vendors.
Requirements
- Bachelor’s degree in engineering.
- A minimum of 2 years of related experience supporting pharmaceutical manufacturing.
- Strong familiarity with Quality, cGMP, and Safety & Environmental policies and procedures.
- Familiarity with Computerized Maintenance and Management Systems (CMMS).
- Ability to adapt flexibly to the flow of work across Quality and Facility aspects to support the business.
- Effective organizational skills.
- Effective communication and technical writing skills.
- Strong computer skills.
- Ability to work off-shift (second shift), Monday through Friday.
Nice To Haves
- Familiarity with Oral Solid Dosage (OSD) drug product manufacturing equipment and processes.
- Troubleshooting ability in mechanical, electrical, or automation areas.
- Experience with maintenance and engineering techniques and management, and capital project management.
- Independent problem-solving ability.
- Experience with SAP Plant Maintenance, including gatekeeping and work order prioritization.
- Familiarity with eVal/Kneat paperless electronic validation systems.
- Experience with ProCal as a Computerized Calibration Maintenance System (CCMS).
- Familiarity with planning and scheduling practices and business or financial practices.
- Ability to work independently and successfully lead or facilitate tasks.
Responsibilities
- Maintain facility, utilities, and manufacturing equipment in compliance with GMP and safety requirements.
- Apply Reliability Maintenance best practices to support timely availability of clinical and development batches.
- Troubleshoot equipment and partner with GES, Facilities Management, OEMs, and vendors.
- Provide engineering and compliance support for non-sterile process equipment and utilities.
- Support equipment validation from commissioning through decommissioning.
- Manage changes and periodic reviews.
- Investigate deviations, issue Quality Notifications, identify root causes, and establish CAPAs.
- Maintain GMP documentation.
- Support clinical operations.
- Manage purchase orders and capital requests.
- Coordinate installation and commissioning of new equipment.
- Support regulatory interactions as a subject matter expert when needed.
Benefits
- Medical, dental, and vision healthcare benefits
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Eligible for annual bonus and long-term incentive, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
