Principal Project Engineer - Packaging & Device Assembly (US)

About the role

This role sits within the Equipment Engineering team, which delivers solutions for Device Assembly and Finished Goods Packaging systems that ensure safe, efficient and compliant pharmaceutical manufacturing. As Principal Project Engineer, you will lead and manage the technical execution of equipment sub-projects, working with global teams, equipment manufacturers and project teams to deliver capital projects for pre-filled syringe, autoinjector and pen injector assembly systems.

Key responsibilities

• Plan, design and implement mechanical and process engineering projects in line with Roche Guidelines, Global Standards and Health Authority requirements.
• Manage the approved sub-project budget and schedule, set priorities and report progress, risks, mitigations and escalations.
• Act as the main interface with equipment manufacturers, covering technical specifications, design reviews, performance validation and compliance.
• Drive mechanical and automation engineering for assembly systems, and lead FATs, SATs, commissioning and qualification.
• Direct external engineering firms, service providers and contractors.
• Guide project scope, options analysis, planning, scheduling and resource allocation.
• Mentor less experienced engineers and act as a technical SME on manufacturing equipment and machine safety during regulatory inspections and audits.

Required profile

• Bachelor's degree in Mechanical or Chemical Engineering or a related field with 8+ years of experience, or a Master's degree with 6+ years in device assembly or finished goods packaging equipment; an MS in Engineering and/or an MBA is preferred.
• Extensive experience managing international capital projects in device assembly and finished goods packaging, typically with budgets of 18 to 60 million USD.
• Proven experience with equipment manufacturers, FAT/SAT leadership and commissioning and qualification.
• Significant knowledge of FDA, EMA, GMP and machine directive requirements for combination products.
• Significant travel (50%+), including weekly commuting or temporary remote work, and international project assignments of 1 to 3 years; relocation benefits are not available.

What we offer

• Expected salary range of $109,900 to $204,100, depending on experience, qualifications and location.
• A possible discretionary annual bonus based on individual and company performance.
• The position qualifies for the benefits described in the original listing.