Principal Project Engineer Packaging & Device Assembly (US)
About The Position
This role is an integral part of our Equipment Engineering team, dedicated to delivering cutting-edge solutions for Device Assembly and Finished Goods Packaging systems that ensure safe, efficient, and compliant pharmaceutical manufacturing. As a member of this team, you will collaborate with global stakeholders, equipment manufacturers, and multidisciplinary project teams to drive the successful delivery of capital projects. With a focus on innovation, quality, and operational excellence, you will contribute to advancing Roche’s mission of providing life-changing medicines to patients worldwide. The Opportunity As a Principal Project Engineer Packaging & Device Assembly (US), you will lead and manage the technical execution of equipment sub-projects, driving collaboration across global teams and ensuring compliance with industry standards. You will be accountable for delivering innovative, high-quality solutions that support the manufacturing of Roche’s life-saving medicines. Additionally, you will: Independently plan, design, and implement mechanical and process engineering projects, ensuring full compliance with Roche Guidelines, Global Standards, and Health Authority Requirements. Manage the approved sub-project budget and schedule, define priorities, and provide regular updates on progress, risks, mitigation strategies, and escalations. Serve as the primary interface with equipment manufacturers, managing technical specifications, design reviews, performance validation, and compliance requirements. Drive mechanical and automation engineering for state-of-the-art assembly systems for pre-filled syringes, autoinjectors, and pen injectors in compliance with relevant standards and regulations Lead and coordinate Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), commissioning, and qualification activities to ensure operational readiness of equipment. Direct and manage external engineering firms, service providers, and contractors to ensure timely and quality-compliant project execution. Guide overall project scope, including options analysis, project planning, detailed scheduling, and resource allocation. Mentor and coach less experienced engineers, fostering technical growth and professional development across the team. Act as a technical Subject Matter Expert (SME) for manufacturing equipment and machine safety during regulatory inspections and audits.
Requirements
- Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or a related discipline with 8+ of experience, or a Master’s Degree with 6+ years of experience in device assembly or finished goods packaging equipment
- Extensive years of experience in international management of capital projects related to device assembly and finished goods packaging, with typical project budgets ranging from 18 to 60 M USD.
- Proven experience collaborating with equipment manufacturers, leading FAT/SAT efforts, and managing equipment commissioning and qualification activities.
- Significant knowledge of regulatory (FDA, EMA) and GMP requirements, as well as machine directives and relevant standards for combination products with demonstrated success in delivering complex projects in pharmaceutical manufacturing environments.
- Significant travel (50% +) assignment requiring weekly commuting and/ or temporary remote assignment as required to meet the business need (including on-site presence). International project assignment of 1 to 3 years as required to meet the business need.
Nice To Haves
- MS in Engineering and/or an MBA is preferred.
Responsibilities
- Independently plan, design, and implement mechanical and process engineering projects, ensuring full compliance with Roche Guidelines, Global Standards, and Health Authority Requirements.
- Manage the approved sub-project budget and schedule, define priorities, and provide regular updates on progress, risks, mitigation strategies, and escalations.
- Serve as the primary interface with equipment manufacturers, managing technical specifications, design reviews, performance validation, and compliance requirements.
- Drive mechanical and automation engineering for state-of-the-art assembly systems for pre-filled syringes, autoinjectors, and pen injectors in compliance with relevant standards and regulations
- Lead and coordinate Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), commissioning, and qualification activities to ensure operational readiness of equipment.
- Direct and manage external engineering firms, service providers, and contractors to ensure timely and quality-compliant project execution.
- Guide overall project scope, including options analysis, project planning, detailed scheduling, and resource allocation.
- Mentor and coach less experienced engineers, fostering technical growth and professional development across the team.
- Act as a technical Subject Matter Expert (SME) for manufacturing equipment and machine safety during regulatory inspections and audits.
Benefits
- A discretionary annual bonus may be available based on individual and Company performance.
- This position also qualifies for the benefits detailed at the link provided below.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
