88-50100315 Senior Manufacturing Technical Specialist

Roche • Hillsboro, OR

1d • $111,840 - $146,600 • Onsite

About The Position

Genentech, Inc. seeks a Senior Manufacturing Technical Specialist at its Hillsboro, OR location. Duties: Set the strategic direction and framework of the one or multiple programs for the Fill Finish Value Stream in the areas of process development, process improvement, training, quality, and compliance. You will manage the deliverables within the established programs and lead teams in their execution in line with the site strategy. Own and actively manage UPEs, PEs, 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). Perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of HTO manufacturing processes, equipment and facilities (including engineering changes, document changes, validation documentation, etc.). Where applicable perform critical technical and operational review and approval of the actual performance of the processes, equipment and facilities as it relates to the design, start-up, commissioning and qualification of new processes, equipment, procedures and facilities. Implement production and large-scale manufacturing procedures to optimize processes and ensure compliance with regulatory requirements. Manage key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.). Lead and facilitate 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. Support the technical development and learning of Fill Finish and support group staff as related to process improvements, tech transfers and process resolutions. Review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures. Support routine site regulatory inspections as a technical resource and Subject Matter Expert. Lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed. Provide technical support on projects related to manufacturing operations and frontline execution, including decision making authority when required or requested.

Requirements

• Three (3) years experience in job offered or related GMP manufacturing position in the pharmaceutical industry
• 1 year of experience must include: Root Cause Analysis & Structured Problem-Solving (5-Why, Ishikawa, FMEA, A3)
• Process Optimization & Lean Six Sigma
• Manufacturing Execution System (MES)/PharmaSuite System Expertise
• Audit & Inspection Readiness for Global Health Authorities
• GMP Production Operations
• Deviation Management & CAPA Systems
• Deviation Trainer & RCA facilitator
• Regulatory Compliance & Technical Documentation Review (FDA/EMA/ICH Standards)
• Project Management and cross-functional team leadership

Responsibilities

• Set the strategic direction and framework of the one or multiple programs for the Fill Finish Value Stream in the areas of process development, process improvement, training, quality, and compliance.
• Manage the deliverables within the established programs and lead teams in their execution in line with the site strategy.
• Own and actively manage UPEs, PEs, 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).
• Perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of HTO manufacturing processes, equipment and facilities (including engineering changes, document changes, validation documentation, etc.).
• Perform critical technical and operational review and approval of the actual performance of the processes, equipment and facilities as it relates to the design, start-up, commissioning and qualification of new processes, equipment, procedures and facilities.
• Implement production and large-scale manufacturing procedures to optimize processes and ensure compliance with regulatory requirements.
• Manage key operational support activities related to product transfers and new equipment/process start-up (manufacturing readiness and process design, documents, engineering runs, equipment set up, etc.).
• Lead and facilitate 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.
• Support the technical development and learning of Fill Finish and support group staff as related to process improvements, tech transfers and process resolutions.
• Review existing operational and process discrepancies in manufacturing and provide technical expertise to improve procedures.
• Support routine site regulatory inspections as a technical resource and Subject Matter Expert.
• Lead coordination and issue resolution across HTO Manufacturing Operations, support groups and/or projects (e.g. Operations Teams) as needed.
• Provide technical support on projects related to manufacturing operations and frontline execution, including decision making authority when required or requested.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• Benefits detailed at the link provided below. Benefits (https://roche.ehr.com/default.ashx?CLASSNAME=splash)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed