Senior Engineer, Sterile Drug Product Operations

MSD; Italia; Hybride; GBP 70 000 - 95 000; Plein temps

Résumé du poste

MSD is seeking a highly motivated engineer to support sterile drug product manufacture within our External Manufacturing Network in Europe. You will work with strategic partners and senior management to drive technical excellence across multiple facilities, ensuring robust sterilization, validation, and process transfer.

You will lead technical issues, support regulatory inspections, and champion continuous improvement in a global, fast-paced environment with approximately 25% travel.

Qualifications

• Bachelor's degree in engineering or related discipline.
• 7+ years of relevant work experience in manufacturing, startup, and/or tech transfer.
• 3+ years in sterile/aseptic Drug Product processing including formulation and filling.
• Experience in Relationship Management

Responsabilités

• Manage technical issues related to global external manufacturing of commercial Drug Product.
• Provide technical leadership within Technical Operations for sterile Drug Product management.
• Support technical transfers of new sterile Drug Product to contract manufacturing sites.
• Drive change with state-of-the-art technology and processes.
• Lead resolution of technical issues within product lines or major projects.
• Provide leadership for day-to-day technical activities in commercial manufacturing.
• Interface between Technical Operations and third-party drug product manufacturers.
• Support Change Controls, investigations, and CAPAs; assist inspections.
• Lead and coordinate critical technical projects in sterile manufacturing.
• Coordinate cross-functional investigations and CAPA/change control implementations.

Connaissances

Change Control

GMP Knowledge

Process Validation

Tech Transfer

Project Management

Regulatory Compliance

Risk Management

Root Cause Analysis

Cross-functional Collaboration

Strategic Thinking

Documentation

Formation

Bachelor's degree in Engineering

Description du poste

MSD is seeking a highly motivated engineer to support sterile drug product manufacture within our External Manufacturing Network in Europe. You will work with strategic partners and senior management to drive technical excellence across multiple facilities, ensuring robust sterilization, validation, and process transfer.

You will lead technical issues, support regulatory inspections, and champion continuous improvement in a global, fast-paced environment with approximately 25% travel.