Genentech · New York
Product & Programposted 4w ago
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.
The Opportunity
As a Principal Technical Sub-Project Manager (Drug Product Filling & Compounding Equipment), you will lead and manage the technical execution of drug product filling and compounding 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.
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.
Who You Are
You possess a 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 pharmaceutical/biopharmaceutical filling and compounding equipment; an MS in Engineering and/or an MBA is preferred.
You possess extensive years of 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.
You possess 8+ years of specific operational experience with filling and compounding systems and equipment, including aseptic filling, lyophilization, vial/syringe filling, and aseptic compounding systems.
You have proven experience collaborating with equipment manufacturers, leading FAT/SAT efforts, and managing equipment commissioning and qualification activities.
You possess significant knowledge with regulatory compliance (FDA, EMA) and GMP requirements for filling and compounding operations, 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 during FAT/SAT activities). International project assignment of 1 to 3 years as required to meet the business need.
The expected salary range for this position based on the primary location of Oregon is $109,900 - $204,100. 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.
This is an on-site position; no remote options are available at this time.
Relocation benefits are not approved for this posting.
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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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