Senior Process Engineer

Responsibilities

• Employ technical expertise to support manufacturing and manage technology transfer projects.
• Support change management through technical risk assessments and scientific studies.
• Design experiments using Quality by Design (QbD) principles to investigate manufacturing deviations.
• Plan, coordinate, and execute Process Performance Qualification (PPQ) and exhibit batches.
• Manage product lifecycle projects, including API source qualification, hold time extensions, and batch upscale.
• Prepare cleaning validation documentation, including protocols, reports, and annual reviews.
• Lead manufacturing quality investigations, including product impact assessments and CAPA implementation.
• Provide technical support for new product introductions and product transfers.

Requirements

• Degree in a science discipline.
• At least 3 years of experience in the pharmaceutical industry.
• Direct experience working in a sterile manufacturing facility.
• Proven experience in Process Performance Qualification (PPQ).
• Experience in technical investigations and CAPA implementation.
• Strong technical writing skills for scientific protocols and reports.

Preferred Qualifications

• Experience with aseptic filling machines.
• Experience in pharmaceutical compounding.
• Knowledge of single-use systems.

About the Company

Viatris is a global healthcare company dedicated to providing access to high-quality medicines for approximately 1 billion patients annually. Formed by the combination of Mylan and Upjohn, we bridge the gap between generics and brands to empower people worldwide to live healthier at every stage of life.