Sr. Specialist, Compliance/Engineering - Oral Solid Dosage (Onsite)
Merck
9 hours ago
On-site
Rahway, NJ
Operations
Position Summary
- Senior Engineer (2nd Shift) providing engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ, supporting non-sterile OSD (oral solid dosage) process equipment/utilities in GMP manufacturing.
Education / Qualifications
- Bachelor’s degree in engineering and at least 5 years supporting pharmaceutical manufacturing operations for OSD formats.
Required Experience & Skills
- Commissioning and qualification experience for GMP manufacturing equipment in regulated environments.
- Hands-on OSD process equipment/operations: granulation, milling, blending, drying, tablet compression/coating, encapsulation.
- Troubleshooting across mechanical, electrical, and automation systems.
- Knowledge of Quality systems, cGMP, GDocP, and applicable Safety/Environmental policies.
- Root cause analysis and support of technical investigations.
- Familiarity with CMMS/CCMS and validation documentation tools (e.g., Kneat).
- Strong organization, time management, and communication; able to manage multiple priorities and collaborate cross-functionally.
Key Responsibilities
- Independently provide 2nd-shift engineering support for OSD equipment/utilities in GMP environment (minimal supervision).
- Create shift-change notes for 1st shift handoff.
- Act as secondary technical escalation: review procedures, drawings, vendor manuals, and calibration/maintenance records to diagnose/resolve issues.
- Troubleshoot equipment/process issues; implement corrective actions with Operations, Process Engineering, Quality, and site technical teams.
- Support manufacturing activities, deviations, and investigations.
- Provide Quality Engineering support to keep facilities/utilities/equipment compliant and qualified.
- Adhere to safety requirements; author/review/maintain GMP documentation (procedures, IQ/OQ protocols, qualification reports, engineering drawings).
- Execute commissioning/qualification/decommissioning per approved protocols, change controls, and site standards.
Compensation / Benefits
- Annual bonus and long-term incentive (if applicable).
- Salary range: $117,000.00–$184,200.00.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).
- Senior Engineer (2nd Shift) providing engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ, supporting non-sterile OSD (oral solid dosage) process equipment/utilities in GMP manufacturing.
Education / Qualifications
- Bachelor’s degree in engineering and at least 5 years supporting pharmaceutical manufacturing operations for OSD formats.
Required Experience & Skills
- Commissioning and qualification experience for GMP manufacturing equipment in regulated environments.
- Hands-on OSD process equipment/operations: granulation, milling, blending, drying, tablet compression/coating, encapsulation.
- Troubleshooting across mechanical, electrical, and automation systems.
- Knowledge of Quality systems, cGMP, GDocP, and applicable Safety/Environmental policies.
- Root cause analysis and support of technical investigations.
- Familiarity with CMMS/CCMS and validation documentation tools (e.g., Kneat).
- Strong organization, time management, and communication; able to manage multiple priorities and collaborate cross-functionally.
Key Responsibilities
- Independently provide 2nd-shift engineering support for OSD equipment/utilities in GMP environment (minimal supervision).
- Create shift-change notes for 1st shift handoff.
- Act as secondary technical escalation: review procedures, drawings, vendor manuals, and calibration/maintenance records to diagnose/resolve issues.
- Troubleshoot equipment/process issues; implement corrective actions with Operations, Process Engineering, Quality, and site technical teams.
- Support manufacturing activities, deviations, and investigations.
- Provide Quality Engineering support to keep facilities/utilities/equipment compliant and qualified.
- Adhere to safety requirements; author/review/maintain GMP documentation (procedures, IQ/OQ protocols, qualification reports, engineering drawings).
- Execute commissioning/qualification/decommissioning per approved protocols, change controls, and site standards.
Compensation / Benefits
- Annual bonus and long-term incentive (if applicable).
- Salary range: $117,000.00–$184,200.00.
Application Instructions
- Apply at https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).