Senior Equipment Program Lead - Pharma Automation

Roche; Kaiseraugst; Vor Ort; CHF 140.000 - 200.000; Vollzeit

Zusammenfassung

Roche is seeking a senior Equipment Engineering leader to drive end-to-end ownership of complex automated manufacturing lines for Drug Products and Combination Products. You will guide design evaluation, procurement, integration, and qualification across multi-site operations, ensuring adherence to global standards.

You will manage budgets and schedules, oversee interfaces with suppliers, and act as SME for equipment safety during inspections, bringing deep expertise in ISO 13485, EU MDR, and

Qualifikationen

• Bachelor’s or Master’s Degree in Mechanical Engineering, Mechatronics, Automation Engineering or related technical discipline.
• 8–12 years of hands-on experience in equipment engineering, special machine construction, or custom automation in pharma/biotech/medtech.
• Deep technical expertise in managing machine suppliers, FAT/SAT, and mechanical commissioning onsite.
• Strong knowledge of machinery directives, equipment qualification (GMP, GAMP 5), and ISO 13485/EU MDR requirements.
• Proven track record delivering complex equipment engineering projects within mid- to large-scale capital investments.
• Proficient in English; German is an advantage.

Aufgaben

• Provide technical leadership and end-to-end equipment engineering accountability for complex automated manufacturing lines.
• Lead mechanical design evaluation, technical specification, procurement, and integration of customized assembly machines and high-speed packaging equipment.
• Manage the complete project lifecycle from concept through FAT/SAT to qualification and ramp-up.
• Drive mechanical and automation engineering for state-of-the-art assembly systems in compliance with ISO 13485 and EU MDR.
• Lead specialized equipment projects including high-speed cartoning machines, assembly automation, vision inspection, and inline serialization.
• Oversee sub-project budgets, schedules, and engineering resource planning; ensure alignment with suppliers and internal PM.
• Act as the primary technical and commercial interface for equipment suppliers, automation integrators, and technology providers.
• Define and execute equipment qualification strategies (IQ/OQ) per EU GMP, FDA CFR 21, and GAMP 5.
• Serve as SME for manufacturing equipment and machine safety during regulatory inspections and audits.

Kenntnisse

Technical leadership

Project management

Problem solving

Stakeholder communication

Regulatory awareness

Ausbildung

Bachelor’s or Master’s Degree in Mechanical Engineering, Mechatronics, Automation Engineering

Jobbeschreibung

Roche is seeking a senior Equipment Engineering leader to drive end-to-end ownership of complex automated manufacturing lines for Drug Products and Combination Products. You will guide design evaluation, procurement, integration, and qualification across multi-site operations, ensuring adherence to global standards.

You will manage budgets and schedules, oversee interfaces with suppliers, and act as SME for equipment safety during inspections, bringing deep expertise in ISO 13485, EU MDR, and