Manufacturing Technical Specialist

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.). Key Responsibilities New Capabilities and Tech Transfer Support : 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.).

Manufacturing Technical Specialist
Hillsboro, OR
10 Months

In this role, you will support the Process & Compliance team and serve the broader HTO 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.

Key Responsibilities

• New Capabilities and Tech Transfer Support: 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.). 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.).
• Process Optimization & Reliability: Drive business process improvements that significantly enhance operational performance, process capability, and robustness within Aseptic Operations. Provide technical support on projects related to manufacturing operations and frontline execution.
• Technical Change Oversight: Own and actively manage Planned Events, CAPAS, and actions related to operational activities, procedures and processes and compliance thereof. Perform critical technical and operational reviews and approvals for quality records, training and documentation associated with process improvements, engineering changes, process design, and validation.
• Structured Problem-Solving and Deviation Management: Own and actively manage deviations. Lead and facilitate Root Cause Analysis (RCA) 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.

Key Qualifications and Experience

• Bachelor's degree in life sciences, physical sciences, engineering or an equivalent combination of education and 2 years work experience.
• Strong problem-solver and have the demonstrated ability to troubleshoot and resolve process-related issues, ensuring efficient operations and regulatory compliance.
• Possesses working 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.
• 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.
• Experience in technical change implementation, including comprehensive implementation plans for training, documents and process changes to ensure they meet intended purposes and regulatory requirements
• Experience in deviations, root cause analysis and associated remediation plans that effectively reduce repetition and recurrence
• Has implemented process Improvement projects that significantly enhance performance and compliance in the areas of quality, process capability, process reliability, and operational efficiency.

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