Senior Engineering Lead - Sterile Drug Product Manufacturing

Tether; Roma; Hybrid; EUR 45,000 - 77,000; Full time

Job summary

Tether in Rome, Italy, is seeking a highly motivated Engineer to support sterile drug product manufacture within our External Manufacturing Network in Europe. You will lead technical operations, support transfers, and collaborate with external partners to implement state-of-the-art processes.

The role requires a bachelor’s in engineering, 7+ years in pharmaceutical manufacturing with 3+ years in sterile/aseptic processing, strong cross-functional skills, and excellent English.

Qualifications

• Bachelor’s degree in engineering or related discipline.
• At least 7 years in manufacturing (start-up, routine, tech transfer).
• ≥3 years sterile/aseptic Drug Product processing including formulation and filling.
• Experience in Relationship Management.

Responsibilities

• Manage technical issues related to global external manufacturing of commercial Drug Product.
• Provide technical leadership for sterile drug product management.
• Support technical transfers of new sterile drug products to contract sites.
• Drive changes and implement state-of-the-art technology and processes.
• Lead cross-functional teams to manage investigations and CAPAs.
• Interface between Technical Operations and third-party manufacturers.
• Support health authority inspections and regulatory interactions.

Skills

Quality systems

Change Control

GMP

Regulatory compliance

Project management

Cross-functional collaboration

English fluency

Root cause analysis

Risk assessment

Team leadership

Education

Bachelor’s degree in engineering or related field

Job description

Tether in Rome, Italy, is seeking a highly motivated Engineer to support sterile drug product manufacture within our External Manufacturing Network in Europe. You will lead technical operations, support transfers, and collaborate with external partners to implement state-of-the-art processes.

The role requires a bachelor’s in engineering, 7+ years in pharmaceutical manufacturing with 3+ years in sterile/aseptic processing, strong cross-functional skills, and excellent English.