Process Owner, Aseptic Process Simulation

Genentech • Hillsboro, OR

35d • $114,000 - $212,000

About The Position

Hillsboro Technical Operations (HTO) is a drug product & finished goods manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Manufacturing organization at HTO is divided into two groups, Aseptic Operations and Finished Goods,, which combine to produce millions of units of life-saving medicine every year to patients around the world. The Opportunity As Process Owner, Aseptic Process Simulation, you will own, develop, maintain & deploy the overarching strategy for the execution, control, and continuous improvement of aseptic process simulation (Media Fill) program at the Hillsboro Technical Operations site. This role will also act as a central partner and key technical resource within our expansive global network, and will collaborate closely with other experts and stakeholders to ensure a robust, harmonized, and compliant approach. You will define the framework for worst-case scenarios, validation studies and evaluation criteria, and take responsibility for the methodology, planning, execution, and analysis of Media Fills. You will work closely with customers in Manufacturing and Quality Assurance to enable successful, consistent and reliable execution of all media fill activities, and also serve as the main point of contact for all relevant interfaces with Regulatory Authorities and network personnel. You will develop a robust, comprehensive Aseptic Process Simulation (Media Fill) strategy that includes worst-case scenarios rooted in sound, risk-based methodology. You will define simulation parameters in accordance with current regulatory guidelines. You will specify routine and non-routine interventions (e.g. personnel changes, machine stops, interruptions) during simulations. You will manage, oversee and direct Media Fill simulations to ensure all documentation and end-to-end execution is carried out on time, in full. . You will conduct deviation management: Ensure systematic root cause analyses are performed when necessary, assess and escalate issues when action/warning limits are exceeded, and initiate revalidation if applicable. You will serve as central contact for APS at both the site and global level. You will collaborate closely with Manufacturing, Quality Assurance, Engineering, and other Customers and Suppliers. You will ensure GMP-compliant validation practices according to PQS, EU GMP Annex 1, and international guidelines. You will prepare for inspections and audits, train personnel, and support regulatory inspections, responses and submissions.

Requirements

• You hold a Bachelor's degree or equivalent in Engineering, Pharmacy, Microbiology, Natural/Engineering Sciences, or a comparable technical qualification with a minimum of 8+ years experience in a sterile GMP environment; Masters Degree is preferred.
• You have extensive experience and in-depth expertise in aseptic process simulation (Media Fill), process validation, contamination control, and risk analysis.
• You have familiarity with regulatory guidelines (ISO 13408-1, PIC/S, FDA, EU GMP Annex 1)
• You have experience planning, executing, and documenting APS, including controlling conditions, control numbers, and acceptance criteria
• You have a strong foundation in sterilization, first air and aseptic handling principles
• You have strong analytical skills, structured approach, and attention to detail in evaluation and documentation
• You have excellent communication skills and experience working with broad, international networks
• You have experience in interdisciplinary collaboration: Quality Assurance, Manufacturing, MSAT/Engineering, Regulatory
• You have an affinity for continuous improvement, lean principles, and digital tools

Responsibilities

• Develop a robust, comprehensive Aseptic Process Simulation (Media Fill) strategy that includes worst-case scenarios rooted in sound, risk-based methodology.
• Define simulation parameters in accordance with current regulatory guidelines.
• Specify routine and non-routine interventions (e.g. personnel changes, machine stops, interruptions) during simulations.
• Manage, oversee and direct Media Fill simulations to ensure all documentation and end-to-end execution is carried out on time, in full.
• Conduct deviation management: Ensure systematic root cause analyses are performed when necessary, assess and escalate issues when action/warning limits are exceeded, and initiate revalidation if applicable.
• Serve as central contact for APS at both the site and global level.
• Collaborate closely with Manufacturing, Quality Assurance, Engineering, and other Customers and Suppliers.
• Ensure GMP-compliant validation practices according to PQS, EU GMP Annex 1, and international guidelines.
• Prepare for inspections and audits, train personnel, and support regulatory inspections, responses and submissions.

Benefits

• A key role with significant impact on commercial production, right to operate, site strategy, and local & global compliance.
• Close involvement in global network committees and access to professional networks.
• Opportunity to shape and drive aseptic process simulation practices at the Hillsboro site.
• Responsibility for continuous process optimization, audit readiness, and innovation in validation activities.
• Potential for industry-wide collaboration.
• Relocation benefits are provided

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees