Sr. Specialist, Compliance​/Engineering - Oral Solid Dosage; Onsite

Position Summary

Senior Engineer (2nd Shift) in our Company’s Research Labs (Pharm Ops Engineering). Provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. Supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. Operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations.

• Bachelor’s degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats

• Demonstrated commissioning and qualification experience supporting GMP manufacturing equipment in regulated environments
• Hands‑on familiarity with OSD process equipment and operations, including granulation, milling, blending, drying, tablet compression and coating, and encapsulation
• Strong technical troubleshooting capability across mechanical, electrical, and automation systems
• Working knowledge of Quality systems, cGMP requirements, Good Documentation Practices (GDocP), and applicable Safety and Environmental policies and procedures
• Experience performing root cause analysis and supporting technical investigations in a manufacturing environment
• Familiarity with CMMS/CCMS platforms and validation documentation tools (e.g., Kneat)
• Strong organizational, time‑management, and communication skills with the ability to manage multiple priorities independently while collaborating effectively across cross‑functional teams
• Proficient with standard business and documentation software tools

• Independently provide second‑shift engineering support for OSD process equipment and associated utilities within a GMP manufacturing environment, operating with minimal supervision
• Develop and provide shift‑change notes to ensure seamless support to the 1st shift team
• Act as the secondary technical escalation point by reviewing procedures, wiring diagrams, equipment drawings, vendor manuals, and calibration/maintenance records to diagnose and resolve issues
• Support troubleshooting of equipment and process issues, and implement effective corrective actions in collaboration with Operations, Process Engineering, Quality, and site technical teams
• Apply engineering principles and OSD process knowledge to support routine manufacturing activities, deviation response, and investigation efforts
• Provide Quality Engineering support to ensure facilities, utilities, and equipment remain compliant, qualified, and fit for GMP clinical, developmental, and commercial operations
• Adhere to all applicable safety requirements
• Author, review, and maintain GMP documentation, including procedures, IQ/OQ protocols, qualification reports, and engineering drawings, in accordance with site and regulatory requirements
• Execute commissioning, qualification, and decommissioning activities in alignment with approved protocols, change controls, and site standards

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.

Salary range: $ – $ (Based on education, qualifications, experience, skills, location, and business needs).

Shift – 2nd – Evening

No travel required

Domestic relocation supported

Valid driving license not required

Hazardous material exposure – None

Requisition : R394699

Our company is an equal opportunity employer and provides equal opportunity for all employees and applicants. We 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 affirmative action requirements for protected veterans and individuals with disabilities.

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