Specialist, Engineering; Onsite

Position Summary

This engineer role provides on‑site engineering support for the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center, supporting non‑sterile operations within the company’s Research Labs Pharmaceutical Sciences and Pharmaceutical Operations Engineering groups.

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. Tasks include process development, scale‑up, launch, 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 ensure timely availability of clinical and development batches.

• Maintain facility, utilities, and manufacturing equipment in compliance with GMP and Safety requirements.
• Apply reliability maintenance best practices to support clinical and development batches.
• 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, and identify root causes and CAPAs.
• Maintain GMP documentation and support clinical operations.
• Manage purchase orders and capital requests.
• Coordinate installation and commissioning of new equipment.
• Serve as a subject‑matter expert for regulatory interactions when needed.

Bachelor’s degree in engineering plus a minimum of two (2) years of related experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats.

• Strong familiarity with Quality, cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Oral Solid Dosage (OSD) drug product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Proficiency in troubleshooting mechanical, electrical, and automation systems.
• Ability to adapt flexibly to the flow of work across Quality and Facility aspects.
• Effective organizational, communication, and technical writing skills.
• Strong computer skills.

• Maintenance and Engineering techniques, project and capital project management.
• Independent problem‑solving.
• Experience with SAP Plant Maintenance (gatekeeping and work order prioritization).
• Experience with eVal/Kneat paperless electronic validation system.
• Experience with Pro Cal as a Computerized Calibration Maintenance System (CCMS).
• Familiarity with planning and scheduling practices and business/financial practices.

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 EEOC Know Your Rights and EEOC GINA Supplement.