Sr./Principal Manufacturing Specialist, Finished Goods

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 manufacturing operations, which combine to produce millions of units of life-saving medicine every year to patients around the world. 

This role is part of the finished goods value stream and will collaborate with frontline, quality, and engineering to provide end-to-end oversight, management, and optimization of the manufacturing processes in the Value Stream. 

The Opportunity

As a Principle Manufacturing Support Specialist, you will support the Process & Compliance team and serve the broader finished goods manufacturing organization. Your work will involve leading a diverse group of efforts to streamline our current processes, in addition to new projects, that enable the FG long-term strategic vision. The work you perform will involve use of many site tools, including RCA, standard work, KPI tracking, and LEAN manufacturing methodologies to identify and drive value for the FG department. You will succeed in this role through close cross-functional collaboration with our training specialists, deviation management, continuous improvement, data analysis, and documentation update sub teams. 

• You will leverage technical expertise to author, edit, and review enabling documents for the finished goods team. 

• You will be a departmental SME that is confident in speaking with inspectors, performing tours, and authoring inspection reports and responses. 

• You will track and identify document corrections, correction trends and coaching to improve documentation proficiency.

• You possess the ability to influence without authority and balance multiple priorities to meet project and site deadlines. 

• You will work effectively and efficiently both in a team-oriented and independent environment to ensure maximum and high- quality output.

• You will lead projects for the finished goods team, including protocol creation for non-routine operations.

• You will lead Root Cause Analysis and Structured Problem-Solving events and actively manage deviations, change records, and compliance actions related to operational activities, procedures and processes. Provide assessments on UPEs and PEs and Global Documents to identify gaps, ensure implementation plans are complete and will meet their intended purpose(s).

• You will adhere to all plant safety policies and procedures and proactively identify unsafe conditions.

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 8+ years of progressive experience in the pharmaceutical industry.

• You are a strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.

• You have a proven track record of working with large datasets (both structured and unstructured), presenting that data in meaningful ways and deriving actionable insights; presenting insights back to stakeholders.

• You possess a deep understanding of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) in pharmaceutical manufacturing.

• 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 Finished Goods processes & equipment, which includes knowledge of upstream aseptic manufacturing processing equipment and materials,  such as isolators, filling, inspection & packaging machines, and sterilization systems, as well as the associated regulatory requirements.

• You are experienced in driving continuous improvement initiatives related to process, equipment, and quality systems.  

The expected salary range for the Sr. level based on the primary location for this position of Hillsboro, OR is $80,500 to $149,500.  Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary