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 Operations organization at HTO is divided into 2 value streams, which combine to produce millions of units of life-saving medicine every year to patients around the world. 

The Manufacturing Training Specialist is a key member of the fill finish value stream and will collaborate with learning management, frontline, quality, and engineering to provide end-to-end oversight, management, and optimization of the training program in the Value Stream. 

The Opportunity:

In this exciting role, you will provide training management, oversight, and technical support to ensure training compliance and departmental capability.  You will support the Process & Compliance team and serve the broader Fill Finish Manufacturing organization by driving business process improvements that significantly enhance operational performance and customer satisfaction, in the areas of quality, process capability, process reliability and robustness, operational efficiency, and standard work. You will achieve this through cross-functional collaboration within 2 workstreams: Advance & Enable. The “Advance Team” sets the conditions for new process implementation, process validation, tech transfer & launch activities, and execution of process improvement initiatives; while the “Enable Team'' performs Batch Record Review, drives root cause analysis & CAPA determination, owns & improves Quality documents, defines key performance indicators and delivers business insights through data analytics & visualization. 

You will be responsible for setting the strategic direction and framework of the Fill Finish Value Stream training program in the areas of process development, process improvement, training, quality, and compliance. You will manage the deliverables within the established program and lead the training team in the execution and management of training requirements within aseptic operations.

You will collaborate with leadership, training client managers, and training program coordinators to develop and assign the appropriate training content and curricula for manufacturing operations in alignment with operational needs, internal policy and requirements, and in compliance with health authority regulations. 

You will support leadership in monitoring timely training completion, compliance and effectiveness. You will ensure training gaps are appropriately resolved and actions are taken in a timely manner in response. 

You will  be accountable for managing key training support and operational activities related to product transfers and new equipment/process start-up (e.g., development of training material in collaboration with engineering, technical support and manufacturing to ensure that course material adheres to compliance requirements and will effectively build departmental capability).

You will  support the technical development and learning of Fill Finish and support group staff as it relates to process improvements, tech transfers, regulatory compliance, and new equipment/new process introduction. You will  review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures and associated training.

You will instruct and facilitate learning programs (both soft skills and technical as needed), which may include coordinating and developing training materials.

You will actively pursue knowledge of standard methodologies and innovative technologies and processes in organization and training effectiveness to develop and improve departmental capabilities.

You will support routine site regulatory inspections as a technical resource and Subject Matter Expert.

You will manage changes related to operational activities, procedures and processes. Provide assessments on CAPAs, change records, deviations and global procedures to identify gåps, ensure implementation plans are complete and will meet their intended purpose(s).

You will support resolution of discrepancies particularly as it relates to operational, training, and process issues, including facilitating Root Cause Analysis and Structured Problem-Solving events, to ensure unplanned/unexpected events are thoroughly investigated and the appropriate remediation actions are defined and pursued, to ultimately reduce the number of repeat/recurring events.

Who you are:

You hold a Bachelor’s degree in life sciences, physical sciences, engineering or an equivalent combination of education and work experience.

You have 4-7 years of progressive experience in the pharmaceutical industry in a training/learning management and/or technical training development role.

You have a fundamental, working knowledge of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in aseptic processing and production.

You have a working knowledge of aseptic processing principles, regulations, and industry guidelines relevant to biologics processing, including knowledge of quality assurance principles, quality systems, microbiology, and sterility assurance.

You possess knowledge of scientific and engineering principles relevant to Aseptic Process & Equipment, which includes knowledge of aseptic manufacturing processing equipment and materials, such as isolators, filling, inspection & packaging machines, and sterilization systems, as well as the associated regulatory requirements.

The expected salary range for this position based on the primary location of Hillsboro, Oregon is $79,000 to $143,00.  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 at the link provided below.

This position is not eligible for relocation benefits or for full time remote work arrangements.

Link to Roche/Genentech Benefits 

Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.