Senior Biologics External Manufacturing Engineer

MSD Malaysia; West Point (PA); On-site; USD 117,000 - 184,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations to support drug substance tech transfer and commercial manufacturing with external partners in our network.

The role emphasizes leadership of technical transfer activities, GMP documentation review, and driving process improvements while ensuring regulatory readiness and compliant operations for sterile biologics manufacturing.

Qualifications

• Minimum of 8 years post-bachelor's degree experience in a GMP functional area.
• Ability to work independently with strong organizational skills.
• Strong communication, problem-solving, and risk assessment abilities.

Responsibilities

• Lead and act as primary interface on technical issues between operations and external drug substance manufacturers.
• Manage technical transfer activities and GMP documentation (MBRs, change controls, protocols, reports).
• Drive process improvements, statistics, and investigations related to commercial manufacturing.
• Ensure readiness for regulatory inspections and adherence to GMP requirements across external partners.
• Collaborate with quality, regulatory, and partner teams to standardize work and best practices.

Skills

GMP Compliance

Technical Transfer

Project Management

Analytical Skills

Communication

Team Leadership

Education

Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology

Job description

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Specialist (Engineering) for Biologics External Manufacturing Technical Operations to support drug substance tech transfer and commercial manufacturing with external partners in our network.

The role emphasizes leadership of technical transfer activities, GMP documentation review, and driving process improvements while ensuring regulatory readiness and compliant operations for sterile biologics manufacturing.