Sr. Scientist – TS/MS Visual Inspection

About the role

The Sr. Scientist – TS/MS Visual Inspection role provides technical guidance for visual inspection operations and projects involving existing and new inspection processes.

Responsibilities

• Understand the scientific principles required for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Provide technical oversight regarding defect classification, visual inspection technique, and visual inspection qualification program to support production operations.
• Perform root cause analysis and apply scientific principles and understanding related to defect creation, prevention, and detection.
• Author, review, approve and provide technical support for the preparation of technical documents, including personnel qualification strategies, control strategies, investigations, change controls, expert opinions, procedures, processing records, validation protocols and summary reports, defect classifications, technical studies, regulatory submissions, etc.
• Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality.
• Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability. Apply process knowledge and data analysis skills to support the management of daily manufacturing operations.
• Serve as technical interface external to the Kenosha site.
• Provide audit support, as needed.
• Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
• Collaborate with and influence partners across the Parenteral Network and teams along a specific product supply chain.
• Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.

Requirements

• Bachelor's Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or other related scientific discipline
• Minimum 10 years of visual inspection experience within the life science industry
• Experience in TS/MS, MSAT, Quality, Engineering, or Operations
• Experience with data trending and analysis
• Previous experience with deviation and change management systems

Qualifications

• Ability to analyze complex data and solve problems
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization