Senior Technical Sub-Project Manager for Drug Substance Equipment

Roche • Oceanside, CA

1d • Onsite

About The Position

This role is an integral part of our Equipment Engineering team, which is dedicated to supporting the delivery of high-quality biologics through the design and implementation of advanced upstream (USP) and downstream (DSP) process equipment. By joining this team, you will collaborate with global stakeholders, technical experts, and equipment manufacturers to lead complex capital projects and drive innovative solutions. Together, we aim to enable compliant and reliable drug substance manufacturing, ensuring life-saving medicines reach patients around the world. The Opportunity As the Senior Technical Sub-Project Manager for Drug Substance Upstream and Downstream biologics process equipment, you will provide technical leadership and accountability for delivering complex engineering projects to support Roche's global manufacturing operations. You will collaborate with diverse stakeholders and manage end-to-end project execution to ensure timely, quality-compliant, and cost-effective outcomes. Additionally, you will: Lead the planning, design, and implementation of biologics process equipment projects, ensuring adherence to Roche guidelines, industry standards, and regulatory requirements. Manage project budgets, schedules, risks, and resources while providing regular updates to ensure alignment with key stakeholders and project goals. Drive decision-making processes and define roles and responsibilities within multidisciplinary project teams. Coordinate and conduct Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), equipment commissioning, and qualification activities to meet GMP compliance and operational readiness requirements. Serve as the technical interface with equipment manufacturers, overseeing design reviews, performance validation, and compliance management. Build and maintain strong working relationships with internal teams, external vendors, and engineering firms to ensure successful project execution. Provide mentorship and technical guidance to less experienced engineers, fostering skill development and team growth.

Requirements

• Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or related discipline with 8+ years of experience preferably in pharmaceutical biologics drug substance equipment, 6+ years of experience with a Master’s Degree.
• Experience managing international capital projects related to biologics drug substance equipment, with typical project budgets ranging from 15 to 50m CHF.
• Operational experience with biologics drug substance equipment (bioreactors, chromatography skids, filtration systems, centrifuges, laminar flow hoods, etc.).
• Experience with equipment manufacturer collaboration, FAT/SAT execution, and equipment commissioning/qualification activities.
• Demonstrated ability to execute highly complex scope on mid-sized to large-scale projects.
• Experience with regulatory compliance (FDA, EMA) and GMP requirements for biologics manufacturing operations.
• Project delivery experience in pharmaceutical manufacturing environments.
• Significant travel (50-60%) assignment requiring weekly commuting and/or temporary remote assignment as required to meet the business need (including on-site presence during FAT/SAT activities).
• International project assignment of 1 to 3 years as required to meet the business need.

Nice To Haves

• MS in Engineering (Chemical or Mechanical) and/or an MBA

Responsibilities

• Lead the planning, design, and implementation of biologics process equipment projects, ensuring adherence to Roche guidelines, industry standards, and regulatory requirements.
• Manage project budgets, schedules, risks, and resources while providing regular updates to ensure alignment with key stakeholders and project goals.
• Drive decision-making processes and define roles and responsibilities within multidisciplinary project teams.
• Coordinate and conduct Factory Acceptance Tests (FAT), Site Acceptance Tests (SAT), equipment commissioning, and qualification activities to meet GMP compliance and operational readiness requirements.
• Serve as the technical interface with equipment manufacturers, overseeing design reviews, performance validation, and compliance management.
• Build and maintain strong working relationships with internal teams, external vendors, and engineering firms to ensure successful project execution.
• Provide mentorship and technical guidance to less experienced engineers, fostering skill development and team growth.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees