CQV Engineer: Second-Shift for GMP Validation

MSD Malaysia; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Job summary

MSD Malaysia seeks an Associate Engineer to provide engineering, CQV and quality support at the Rahway, NJ FLEx center. The role focuses on GMP-compliant equipment, facilities, utilities and systems, with second-shift availability and on-call support.

Responsibilities include CQV documentation, commissioning, qualification, validation, and participation in audits, CAPA, and risk assessments to ensure timely clinical supplies and development batches.

Qualifications

• Bachelor’s degree in Mechanical or Chemical Engineering required.
• Experience with cGMP and GMP pharmaceutical manufacturing operations preferred.
• Strong Troubleshooting skills across mechanical, electrical and automation domains.

Responsibilities

• Provide engineering and quality engineering support for facilities, utilities and equipment to be suitable for GMP and developmental use.
• Troubleshoot equipment and drive operational improvements; support protocol development.
• Develop, author, execute, and maintain CQV documentation (commissioning, qualification, validation) and ensure compliance with GMP.
• Support QA activities, CAPA development, FMEAs/PHAs and risk assessments; participate in audits and regulatory inspections.

Skills

Equipment Commissioning

Equipment Qualification

Equipment Validation

GMP Guidelines

CMMS

CQV

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

MSD Malaysia seeks an Associate Engineer to provide engineering, CQV and quality support at the Rahway, NJ FLEx center. The role focuses on GMP-compliant equipment, facilities, utilities and systems, with second-shift availability and on-call support.

Responsibilities include CQV documentation, commissioning, qualification, validation, and participation in audits, CAPA, and risk assessments to ensure timely clinical supplies and development batches.