CQV Associate Engineer – GMP Facilities & Validation

Merck & Co.; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co. in Rahway, NJ, is seeking an Associate Engineer to provide engineering, CQV, and quality engineering support for the Formulation, Laboratory & Experimentation center. The role focuses on GMP-compliant facilities, utilities and equipment across development and clinical programs.

You will collaborate with Facilities Management, OEMs and vendors to sustain operations, support audits, and drive CAPA, QMS activities, with second-shift availability and on-call as needed.

Qualifications

• Bachelor's degree in Mechanical or Chemical Engineering is required.
• Minimum 1 year of pharmaceutical experience or relevant internship.
• Experience with cGMP, GDocP, and GMP manufacturing operations.
• Knowledge of commissioning and qualification/validation processes, including periodic review.
• Familiar with regulatory requirements for GMP facilities and equipment.

Responsibilities

• Provide engineering and quality engineering support for facilities, utilities and equipment to be suitable for GMP and developmental use.
• Troubleshoot equipment (mechanical/electrical/automation), drive operational improvements, and contribute to protocol development.
• Participate in and support continuous improvement activities within the non-sterile modality to expand equipment and operational efficiencies.
• Develop, author, execute, and maintain CQV documentation (commissioning, qualification, validation protocols, reports, Validation Master Plans, Project Execution Plans, schedules)
• Perform commissioning, qualification, decommissioning, and periodic review activities for equipment, systems and critical utilities.
• Support installation of new capital/facility improvements and provide capital project support for small and large multidisciplinary projects.
• Maintain GMP documentation (e.g., GMP engineering drawings, equipment database tracking) and ensure Good Documentation Practices.
• Participate in Quality Notifications (QN), investigations, root cause analysis, CAPA development and implementation, FMEAs, PHAs and other risk assessments.
• Support internal and external audits and regulatory inspections; provide timely, accurate responses to observations/questions.
• Facilitate equipment/system changes, support QMS activities, and execute business-aligned periodic reviews.

Skills

CQV

GMP

CMMS

Equipment Commissioning

Equipment Qualification

Equipment Validation

Good Documentation Practices

Process Engineering

Troubleshooting

Reliability Maintenance

Education

Bachelor's degree in Mechanical or Chemical Engineering

Tools

ProCal CMMS

CCMS (SAP Plant Maintenance)

Kneat

eVal

Job description

Merck & Co. in Rahway, NJ, is seeking an Associate Engineer to provide engineering, CQV, and quality engineering support for the Formulation, Laboratory & Experimentation center. The role focuses on GMP-compliant facilities, utilities and equipment across development and clinical programs.

You will collaborate with Facilities Management, OEMs and vendors to sustain operations, support audits, and drive CAPA, QMS activities, with second-shift availability and on-call as needed.