Principal MSAT Engineer (AVI & Device)

INCOG BioPharma Services • Fishers, IN

1d • Onsite

About The Position

The Principal MSAT Engineer for Automated Vision Inspection & Device is an exciting role in a fast-growing team with lot of growth opportunities. This role is responsible for overseeing and enhancing the visual inspection program to ensure the highest quality standards for Biopharmaceuticals products. This role involves providing expert guidance on inspection methodologies, leading training programs, optimizing systems, and ensuring compliance with regulatory requirements. The person in this role will also leverage in-depth technical knowledge and strong analytical skills to drive product quality and patient safety.

Requirements

• Bachelor’s degree in Chemistry, Engineering, or a related field; Advanced degree preferred.
• 10+ years of experience working in a GMP-regulated environment
• 5+ years of experience in visual inspection for biopharmaceutical products
• In-depth knowledge of visual inspection standards, practices, and equipment
• Familiarity with regulatory guidance (FDA, EMA) and experience in regulatory inspections.

Nice To Haves

• Proven record of developing training programs and mentoring inspection team
• Experience with automated visual inspection systems

Responsibilities

• Lead the design, development, and implementation of risk-based strategies for visual inspection of different products (e.g., syringes, cartridges, vials)
• Serve as go-to expert on visual inspection processes, equipment and quality standards.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA) for quality-related events.
• collaborate with cross-functional teams involving process engineering, operations, quality assurance to identify and implement process improvements.
• Ensure compliance with FDA and global regulatory bodies by keeping inspection processes and documentation up to date.
• Act as a subject matter expert for the development and maintenance of internal strategy documents and execution documents to support visual inspection programs.
• Participate in internal and external audits, providing expert insights and support.
• Explore and evaluate new technologies and methodologies in visual inspection.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal