Manufacturing Specialist

Job Description

Job Description

The role will drive business process improvements that enhance operational performance and customer satisfaction in quality, process capability, reliability and robustness, operational efficiency, and standard work. The ideal candidate will have experience in aseptic operations, technical change implementation, and structured problem solving to achieve measurable improvements in compliance and performance.

Responsibilities:

• New Capabilities and Tech Transfer Support: Manage operational support for product transfers and new equipment or process start-up, including manufacturing readiness, process design, documentation, engineering runs, and equipment setup. Perform technical and operational reviews and approvals of documentation related to design, validation, operation, and maintenance of HTO manufacturing processes, equipment, and facilities.
• Process Optimization & Reliability: Drive process improvements that enhance operational performance, capability, and robustness within Aseptic Operations. Provide technical support for projects related to manufacturing operations and frontline execution.
• Technical Change Oversight: Own and manage Planned Events, CAPAs, and actions related to operational activities, procedures, processes, and compliance. Perform 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 manage deviations. Lead and facilitate Root Cause Analysis and structured problem-solving events to investigate unplanned events and define remediation actions to reduce repeat occurrences.

Required Skills & Qualifications:

• Bachelor’s degree in life sciences, physical sciences, engineering, or an equivalent combination of education and 2 years of work experience.
• Demonstrated ability to troubleshoot and resolve process-related issues while ensuring efficient operations and regulatory compliance.
• Working knowledge of scientific and engineering principles relevant to aseptic process and equipment, including isolators, filling, inspection and packaging machines, and sterilization systems, with understanding of associated regulatory requirements.
• Working knowledge of aseptic processing principles, regulations, and industry guidelines for biologics, including quality assurance, quality systems, microbiology, and sterility assurance.
• Experience implementing technical changes with comprehensive plans for training, documentation, and process changes that meet intended purposes and regulatory requirements.
• Experience leading deviations, root cause analysis, and remediation plans that reduce recurrence.
• Proven delivery of process improvement projects that enhance quality, process capability, reliability, and operational efficiency.