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Principal Technical Sub-Project Manager (Drug Product Filling & Compounding Equipment)

$109.9k - $204.1k

F. Hoffmann-La Roche AG

This role is an integral part of our Equipment Engineering team, dedicated to delivering cutting‑edge solutions for drug product filling and compounding 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. 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. 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. Qualifications Hold a Bachelor’s Degree in Mechanical Engineering, Chemical Engineering, or a related discipline with 8+ years of experience, or a Master’s Degree with 6+ years of experience in pharmaceutical/biopharmaceutical filling and compounding equipment (MS in Engineering and/or an MBA is preferred). Have extensive experience in international management of capital projects related to drug product filling and compounding equipment, with typical project budgets ranging from 15 to 50m CHF. Have 8+ years of specific operational experience with filling and compounding systems and equipment, including aseptic filling, lyophilization, vial/syringe filling, and aseptic compounding systems. Demonstrate proven experience collaborating with equipment manufacturers, leading FAT/SAT efforts, and managing equipment commissioning and qualification activities. Possess significant knowledge of regulatory compliance (FDA, EMA) and GMP requirements for filling and compounding operations, with demonstrated success in delivering complex projects in pharmaceutical manufacturing environments. Travel & Assignment Significant travel (50%+) assignment, requiring weekly commuting and/or temporary remote assignment during FAT/SAT activities. International project assignment of 1 to 3 years as required. Compensation Salary range for Oregon: $109,900 – $204,100, based on experience and location. Discretionary annual bonus may be available based on individual and company performance. Benefits Qualified for benefits as detailed in the company documentation. Equal Opportunity Employer Genentech is an equal opportunity employer. Our policies prohibit unlawful discrimination, including protection for veterans and persons with disabilities, in accordance with all applicable laws. Accommodations for applicants with disabilities are available upon request. #J-18808-Ljbffr

Vacancy posted 23 hours ago
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