Sr. Specialist, Compliance/Engineering - Oral Solid Dosage (Onsite)

Job Description

Position Summary

The 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. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations.   

Education

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

Required Experience and Skills

• 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

Key Responsibilities

• 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

#eligibleforERP

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FLEx2026

Required Skills:

Adaptability, Adaptability, Analytical Testing, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, Equipment Troubleshooting, GMP Compliance, Good Manufacturing Practices (GMP), Manufacturing Operations, Pharmaceutical Manufacturing, Pharmaceutical Systems, Procedure Reviews, Process Architecture, Process Design, Process Engineering, Process Hazard Analysis (PHA), Process Optimization, Process Technologies, Protocol Review, Quality Engineering, Root Cause Analysis (RCA), Software Documentation, Strategic Thinking {+ 2 more}

Preferred Skills:

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US and Puerto Rico Residents Only:

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