Sterile Engineering Specialist: Validation & Equipment Lead

Merck; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Merck in Rahway, NJ seeks an Engineer to provide on-site support for sterile operations in the FLEx center within Pharm Ops Engineering. The role covers equipment lifecycle, validation, and cross‑functional collaboration to enable compliant manufacturing of clinical, stability, and developmental sterile products.

You will partner with Operations, Quality, Engineering, and external vendors to install, qualify, validate, and maintain manufacturing equipment and utility systems, ensuring GMP

Qualifications

• Bachelor's degree in engineering or science and a minimum of 2 years of related Drug Product/Sterile/Validation experience.
• Knowledge of cGMP, Safety & Environmental Policies and Procedures.
• Familiarity with Sterile Drug Product manufacturing equipment and process.
• Familiarity with Computerized Maintenance and Management Systems (CMMS).
• Troubleshooting ability (mechanical/electrical/automation).
• Ability to flexibly adapt to flow of the work across both Quality and Facility aspects to support the business.
• Effective organizational skills.
• Effective communication and technical writing skills.
• Strong computer skills.

Responsibilities

• Full equipment lifecycle support from commissioning through decommissioning.
• Authoring, executing, reviewing, and approving qualification and validation documentation.
• Managing equipment and system changes; conducting periodic reviews; supporting investigations, deviations, QNs, and CAPAs.
• Maintaining GMP engineering documentation and asset records, applying reliability-centered maintenance.
• Serving as SME for sterilization and cleaning validation programs; coordinating validation with third-party providers.
• Contractor and vendor oversight, work order governance, and budget support.

Skills

Capital Project Mgmt

cGMP Guidelines

Cleaning Validations

Engineering Support

Equipment Management

Maintenance Mgmt Systems

Pharmaceutical Sciences

Pilot Plant Ops

Quality Engineering

Regulatory Requirements

SOP Writing

Technical Writing

Troubleshooting

Education

Bachelor's degree in Engineering or Science

Tools

SAP PM

eVal/Kneat

ProCal CCMS

CMMS

Job description

Merck in Rahway, NJ seeks an Engineer to provide on-site support for sterile operations in the FLEx center within Pharm Ops Engineering. The role covers equipment lifecycle, validation, and cross‑functional collaboration to enable compliant manufacturing of clinical, stability, and developmental sterile products.

You will partner with Operations, Quality, Engineering, and external vendors to install, qualify, validate, and maintain manufacturing equipment and utility systems, ensuring GMP