Genentech · New York
Otherposted 4w ago
This role is a key part of our Equipment Engineering team, dedicated to delivering cutting-edge solutions for Single-use Systems in biologics manufacturing. As a member of this team, you will play a pivotal role in managing complex projects, collaborating with multidisciplinary teams, and ensuring compliance with industry and regulatory standards. This position offers the opportunity to work with global stakeholders, mentor engineers, and contribute to the advancement of innovative technologies that support our mission of delivering high-quality, life-saving medicines to patients worldwide.
The Opportunity
As a Principal Project Engineer for Single-Use Equipment, you will serve as a technical leader responsible for managing and delivering engineering projects focused on biologics process equipment, ensuring compliance with industry standards, regulatory requirements, and Roche guidelines. You will drive collaboration across disciplines and global stakeholders to achieve project goals while implementing innovative solutions for GMP-compliant manufacturing systems. Additionally, you will:
Lead the planning, design, and execution of engineering projects for single-use biologics process equipment.
Manage sub-project budgets, schedules, resources, and risks to ensure timely and cost-effective project delivery.
Serve as the primary interface with equipment suppliers for technical specifications, design reviews, and performance validation.
Oversee Factory Acceptance Tests, Site Acceptance Tests, and equipment qualification activities, ensuring systems meet GMP compliance.
Develop and manage relationships with external vendors and contractors to ensure quality execution and timely delivery of project scope.
Provide mentoring and technical guidance to less experienced engineers to foster professional growth and team excellence.
Drive alignment with key stakeholders, ensuring consistent communication and decision-making throughout project phases.
Who You Are
Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or related discipline with 8+ years of experience preferably in pharmaceutical biologics molecule drug substance equipment, 6+ years of experience with a Master’s Degree.
Experience managing international capital projects related to biologics molecule drug substance equipment, with typical project budgets ranging from 15 to 50m CHF.
Operational experience with biologics systems (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.
Preferred:
MS in Engineering (Chemical or Mechanical) and/or an MBA
This is an on-site position; no remote options are available at this time.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of California is $109,900 - $204,100 Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed in this link.
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
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